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Self-referral to group cognitive behavioural therapy: Is it effective for treating chronic insomnia?

Objectives: To evaluate the effectiveness of a short (3 session) programme of group cognitive behavioural therapy (CBT) on insomnia, sleepiness and symptoms of anxiety and depression. Methods: Prospective observational study of group CBT with follow-up at 3 months. Participants were self-referred patients with chronic insomnia. Outcome measures were the insomnia severity scale (ISI), the Epworth sleepiness scale (ESS), depression (Pichot scale), and the number of anxiety symptoms. Results: Participation in CBT was offered to 489 patients of whom 474 completed the programme and 154 were followed up at 3 months. Significant improvements in insomnia were seen: ISI score (17.74-14.27, P<0.0001) after CBT and at follow-up (13.78, P<0.0001). At the end of CBT, 76% (59/78) with initial severe insomnia and 52% (132/255) with moderate insomnia were improved, maintained at 3 months in 71% (15/21) with severe insomnia and 56% (50/90) with moderate insomnia. Depression and anxiety symptoms were significantly improved: mean depression symptoms (4.15-3.35, P<0.0001) and anxiety symptoms (4.52-3.95, P<0.0001), maintained at 3 months with mean depression symptoms (3.17, P<0.0001) and mean anxiety symptoms (3.62, P<0.0001). Sleepiness increased between baseline and the end of the group (6.67-7.24, P=0.015) followed by a reduction at 3 months (7.19-6.34 at 3 months, P=0.001). Initial ISI score but neither sex nor age were predictive of outcome. Conclusions: A short programme of CBT can improve sleep, depression and anxiety symptoms in self-referred patients suffering from chronic insomnia with good adherence and maximum benefit in patients with severe insomnia.

L'Encephale · cohort or longitudinal · 6 citationsread the source →

Tiny Habits® for Gratitude-Implications for Healthcare Education Stakeholders.

The COVID-19 pandemic has led to diminished sleep and increased stress, anxiety, and burnout for many health professionals and health professions students. One simple approach that may be effective for bolstering personal well-being is consciously cultivating gratitude. Gratitude is positively associated with physical health, psychological health, hope, sleep, and health behavior engagement; and randomized studies indicate that gratitude interventions can improve psychological well-being and sleep. The primary aim of this study was to assess the impact of practicing Tiny Habits® on self-reported gratitude, as measured by the 6-Item Gratitude Questionnaire (GQ-6). In January 2021, 154 adult participants with GQ-6 <35/42 were randomized to one of 3 groups: Tiny Habits for Gratitude (n = 50), Tiny Habits Control (n = 52), and Inactive Control (n = 52). Both Tiny Habits groups chose 3 Tiny Habits Recipes to practice daily and participated in the free, email-based 5-Day Program with automated daily check-in emails and personalized feedback from a Certified Tiny Habits Coach. The Recipes for the Tiny Habits for Gratitude group focused on cultivating gratitude, while those for the Tiny Habits Control group did not. Post-intervention, the mean change in GQ-6 scores in the Tiny Habits for Gratitude (Δ = ↑6.9 ± 5.6; n = 37/50, 74%; p< 0.001, Cohen's d = 0.85) and Tiny Habits Control (Δ = ↑5.6 ± 4.1; n = 31/52, 60%; p = 0.009, Cohen's d = 0.71) groups were greater than that of the Inactive Control group (Δ = ↑2.5 ± 4.4; N = 42/52, 81%). At 1 month, the mean change in GQ-6 scores in the Tiny Habits for Gratitude group (Δ = ↑7.0 ± 5.3; N = 28/50, 56%) was greater than that of the Inactive Control group (Δ = ↑2.9 ± 5.4; N = 39/52, 72%; p = 0.002, Cohen's d = 0.78). These findings suggest that practicing Tiny Habits Recipes and participating in the 5-Day Program can significantly increase gratitude in the short term and focusing specifically on gratitude during this process can sustain the increase in gratitude for up to 1 month. Implementation is quick, simple, and free. This has significant implications for healthcare education stakeholders.

Frontiers in public health · randomised controlled trial · 5 citationsread the source →

Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer.

Purpose Individuals with advanced cancer experience substantial distress in response to disease burden and impending mortality. Managing Cancer And Living Meaningfully (CALM) is a novel, brief, manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. We conducted a randomized controlled trial to compare CALM with usual care (UC) in this population. Methods Patients with advanced cancer were recruited from outpatient oncology clinics at a comprehensive cancer center into an unblinded randomized controlled trial. Permuted block randomization stratified by Patient Health Questionnaire-9 depression score allocated participants to CALM plus UC or to UC alone. Assessments of depressive symptoms (primary outcome), death-related distress, and other secondary outcomes were conducted at baseline, 3 months (primary end point), and 6 months (trial end point). Analyses were by intention to treat. Analysis of covariance was used to test for outcome differences between groups at follow-up, controlling for baseline. Mixed-model results are reported. Results Participants (n = 305) were recruited between February 3, 2012, and March 4, 2016, and randomly assigned to CALM (n = 151) or UC (n = 154). CALM participants reported less-severe depressive symptoms than UC participants at 3 months (Δ = 1.09; P = .04; Cohen's d = 0.23; 95% CI, 0.04 to 2.13) and at 6 months (Δ = 1.29; P = .02; d = 0.29; 95% CI, 0.24 to 2.35). Significant findings for greater end-of-life preparation at 6 months also favored CALM versus UC. No adverse effects were identified. Conclusion Findings suggest that CALM is an effective intervention that provides a systematic approach to alleviating depressive symptoms in patients with advanced cancer and addresses the predictable challenges these patients face.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 205 citationsread the source →

Effectiveness of 234 interventions to improve life satisfaction: A rapid systematic review.

This rapid review evaluates interventions aimed at improving life satisfaction and aids policymakers, researchers, and practitioners by identifying research strengths, gaps, and future directions for life satisfaction research. Intervention inclusion criteria were: use of a control group; delivered in high-income OECD country; randomised control trials or quasi-experimental studies; published between Jan 2011-Oct 2023; English language; uses a validated life satisfaction outcome measure. Of 9520 search results across five academic databases and grey literature sources, a total of 189 studies with 234 intervention arms met criteria for inclusion. The six themes (18 total subthemes) identified were: Emotion-based activities (intrapersonal and interpersonal, n = 154); Didactic emotional development (n = 30); Health promotion (n = 31); Social media (n = 4); Music (n = 3); and Multi-component interventions (n = 12). Meta-analyses were possible in six subthemes and examined overall standardised mean differences (SMD) in life satisfaction from pre-to post-intervention between the intervention and control group. The review primarily identified intrapersonal (related to self) emotional activities as generally associated with small improvements in life satisfaction: mindfulness (SMD: 0.28 (95% Confidence Interval: 0.13, 0.42)), gratitude (0.19 (0.11, 0.27)) and therapy (0.33 (0.12, 0.53)). Additionally, meta-analysis revealed a moderate effect of emotional skills development training (SMD 0.50 (0.12, 0.88)) and a small effect of exercise (SMD: 0.33 (0.04, 0.62)) on life satisfaction. Subthemes with mixed evidence (i.e., some interventions were effective while others were not) included: positivity and prosocial activities, emotional regulation and resilience training, health promotion education, 'other' intrapersonal emotion-based activities which could not otherwise be categorised, and multi-component interventions. The findings of this rapid review offer comprehensive insight into effective interventions for improving life satisfaction as well as areas for further research.

Social science & medicine (1982) · systematic review · 5 citationsread the source →

Evaluation of the Effectiveness of Digital Technology Interventions to Reduce Loneliness in Older Adults: Systematic Review and Meta-analysis.

Background: Loneliness is a serious public health issue, and its burden is increasing in many countries. Loneliness affects social, physical, and mental health, and it is associated with multimorbidity and premature mortality. In addition to social interventions, a range of digital technology interventions (DTIs) are being used to tackle loneliness. However, there is limited evidence on the effectiveness of DTIs in reducing loneliness, especially in adults. The effectiveness of DTIs in reducing loneliness needs to be systematically assessed. Objective: The objective of this study is to assess the effectiveness of DTIs in reducing loneliness in older adults. Methods: We conducted electronic searches in PubMed, MEDLINE, CINAHL, Embase, and Web of Science for empirical studies published in English from January 1, 2010, to July 31, 2019. The study selection criteria included interventional studies that used any type of DTIs to reduce loneliness in adults (aged ≥18 years) with a minimum intervention duration of 3 months and follow-up measurements at least 3 months after the intervention. Two researchers independently screened articles and extracted data using the PICO (participant, intervention, comparator, and outcome) framework. The primary outcome measure was loneliness. Loneliness scores in both the intervention and control groups at baseline and at follow-up at 3, 4, 6, and 12 months after the intervention were extracted. Data were analyzed via narrative synthesis and meta-analysis using RevMan (The Cochrane Collaboration) software. Results: A total of 6 studies were selected from 4939 screened articles. These studies included 1 before and after study and 5 clinical trials (4 randomized clinical trials and 1 quasi-experimental study). All of these studies enrolled a total of 646 participants (men: n=154, 23.8%; women: n=427, 66.1%; no gender information: n=65, 10.1%) with an average age of 73-78 years (SD 6-11). Five clinical trials were included in the meta-analysis, and by using the random effects model, standardized mean differences (SMDs) were calculated for each trial and pooled across studies at the 3-, 4-, and 6-month follow-ups. The overall effect estimates showed no statistically significant difference in the effectiveness of DTIs compared with that of usual care or non-DTIs at follow-up at 3 months (SMD 0.02; 95% CI -0.36 to 0.40; P=.92), 4 months (SMD -1.11; 95% CI -2.60 to 0.38; P=.14), and 6 months (SMD -0.11; 95% CI -0.54 to 0.32; P=.61). The quality of evidence was very low to moderate in these trials. Conclusions: Our meta-analysis shows no evidence supporting the effectiveness of DTIs in reducing loneliness in older adults. Future research may consider randomized controlled trials with larger sample sizes and longer durations for both the interventions and follow-ups. International registered report identifier (irrid): RR2-10.1136/bmjopen-2019-032455.

Journal of medical Internet research · meta-analysis · 78 citationsread the source →

Child protection training for professionals to improve reporting of child abuse and neglect.

Background: Many nations require child-serving professionals to report known or suspected cases of significant child abuse and neglect to statutory child protection or safeguarding authorities. Considered globally, there are millions of professionals who fulfil these roles, and many more who will do so in future. Ensuring they are trained in reporting child abuse and neglect is a key priority for nations and organisations if efforts to address violence against children are to succeed. Objectives: To assess the effectiveness of training aimed at improving reporting of child abuse and neglect by professionals and to investigate possible components of effective training interventions. Search methods: We searched CENTRAL, MEDLINE, Embase, 18 other databases, and one trials register up to 4 June 2021. We also handsearched reference lists, selected journals, and websites, and circulated a request for studies to researchers via an email discussion list. Selection criteria: All randomised controlled trials (RCTs), quasi-RCTs, and controlled before-and-after studies examining the effects of training interventions for qualified professionals (e.g. teachers, childcare professionals, doctors, nurses, and mental health professionals) to improve reporting of child abuse and neglect, compared with no training, waitlist control, or alternative training (not related to child abuse and neglect). Data collection and analysis: We used methodological procedures described in the Cochrane Handbook for Systematic Reviews of Interventions. We synthesised training effects in meta-analysis where possible and summarised findings for primary outcomes (number of reported cases of child abuse and neglect, quality of reported cases, adverse events) and secondary outcomes (knowledge, skills, and attitudes towards the reporting duty). We used the GRADE approach to rate the certainty of the evidence. Main results: We included 11 trials (1484 participants), using data from 9 of the 11 trials in quantitative synthesis. Trials took place in high-income countries, including the USA, Canada, and the Netherlands, with qualified professionals. In 8 of the 11 trials, interventions were delivered in face-to-face workshops or seminars, and in 3 trials interventions were delivered as self-paced e-learning modules. Interventions were developed by experts and delivered by specialist facilitators, content area experts, or interdisciplinary teams. Only 3 of the 11 included studies were conducted in the past 10 years. Primary outcomes Three studies measured the number of cases of child abuse and neglect via participants' self-report of actual cases reported, three months after training. The results of one study (42 participants) favoured the intervention over waitlist, but the evidence is very uncertain (standardised mean difference (SMD) 0.81, 95% confidence interval (CI) 0.18 to 1.43; very low-certainty evidence). Three studies measured the number of cases of child abuse and neglect via participants' responses to hypothetical case vignettes immediately after training. A meta-analysis of two studies (87 participants) favoured training over no training or waitlist for training, but the evidence is very uncertain (SMD 1.81, 95% CI 1.30 to 2.32; very low-certainty evidence).  We identified no studies that measured the number of cases of child abuse and neglect via official records of reports made to child protection authorities, or adverse effects of training. Secondary outcomes Four studies measured professionals' knowledge of reporting duty, processes, and procedures postintervention. The results of one study (744 participants) may favour the intervention over waitlist for training (SMD 1.06, 95% CI 0.90 to 1.21; low-certainty evidence). Four studies measured professionals' knowledge of core concepts in all forms of child abuse and neglect postintervention. A meta-analysis of two studies (154 participants) favoured training over no training, but the evidence is very uncertain (SMD 0.68, 95% CI 0.35 to 1.01; very low-certainty evidence). Three studies measured professionals' knowledge of core concepts in child sexual abuse postintervention. A meta-analysis of these three studies (238 participants) favoured training over no training or waitlist for training, but the evidence is very uncertain (SMD 1.44, 95% CI 0.43 to 2.45; very low-certainty evidence). One study (25 participants) measured professionals' skill in distinguishing reportable and non-reportable cases postintervention. The results favoured the intervention over no training, but the evidence is very uncertain (SMD 0.94, 95% CI 0.11 to 1.77; very low-certainty evidence). Two studies measured professionals' attitudes towards the duty to report child abuse and neglect postintervention. The results of one study (741 participants) favoured the intervention over waitlist, but the evidence is very uncertain (SMD 0.61, 95% CI 0.47 to 0.76; very low-certainty evidence). Authors' conclusions: The studies included in this review suggest there may be evidence of improvements in training outcomes for professionals exposed to training compared with those who are not exposed. However, the evidence is very uncertain. We rated the certainty of evidence as low to very low, downgrading due to study design and reporting limitations. Our findings rest on a small number of largely older studies, confined to single professional groups. Whether similar effects would be seen for a wider range of professionals remains unknown. Considering the many professional groups with reporting duties, we strongly recommend further research to assess the effectiveness of training interventions, with a wider range of child-serving professionals. There is a need for larger trials that use appropriate methods for group allocation, and statistical methods to account for the delivery of training to professionals in workplace groups.

The Cochrane database of systematic reviews · meta-analysis · 25 citationsread the source →

A double-blind, randomized controlled clinical trial comparing eicosapentaenoic acid versus docosahexaenoic acid for depression.

Objective: To compare 2 omega-3 (n-3) preparations enriched with eicosapentaenoic acid (EPA) versus docosahexaenoic acid (DHA) as monotherapy for major depressive disorder (MDD) in a 2-site, placebo-controlled, randomized, double-blind clinical trial. Method: 196 adults (53% female; mean [SD] age = 44.7 [13.4] years) with DSM-IV MDD and a baseline 17-item Hamilton Depression Rating Scale (HDRS-17) score ≥ 15 were randomized equally from May 18, 2006, to June 30, 2011, to 8 weeks of double-blind treatment with oral EPA-enriched n-3 1000 mg/d, DHA-enriched n-3 1,000 mg/d, or placebo. Results: 154 subjects completed the study. Modified intent-to-treat (mITT) analysis (n = 177 subjects with ≥ 1 postbaseline visit; 59.3% female, mean [SD] age 45.8 [12.5] years) employed mixed-model repeated measures (MMRM). All 3 groups demonstrated statistically significant improvement in the HDRS-17 (primary outcome measure), 16-item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16), and Clinical Global Improvement-Severity Scale (CGI-S) (P < .05), but neither n-3 preparation separated from placebo (P > .05). Response and remission rates were in the range of 40%-50% and 30%, respectively, for all treatments, with no significant differences between groups. One subject receiving EPA-enriched n-3 discontinued due to worsening depression, and 1 subject receiving placebo discontinued due to an unspecified "negative reaction" to pills. Conclusions: Neither EPA-enriched nor DHA-enriched n-3 was superior to placebo for the treatment of MDD. Trial registration: ClinicalTrials.gov identifier: NCT00517036.

The Journal of clinical psychiatry · randomised controlled trial · 61 citationsread the source →

Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster randomised trial.

Background: Parenting interventions have been implemented to improve the compromised developmental potential among 39% of children younger than 5 years living in low-income and middle-income countries. Maternal wellbeing is important for child development, especially in children younger than 3 years who are vulnerable and dependent on their mothers for nutrition and stimulation. We assessed an integrated, community-based parenting intervention that targeted both child development and maternal wellbeing in rural Uganda. Methods: In this community-based, cluster randomised trial, we assessed the effectiveness of a manualised, parenting intervention in Lira, Uganda. We selected and randomly assigned 12 parishes (1:1) to either parenting intervention or control (inclusion on a waitlist with a brief message on nutrition) groups using a computer-generated list of random numbers. Within each parish, we selected two to three eligible communities that had a parish office or a primary school in which a preschool could be established, more than 75 households with children younger than 6 years, and at least 15 socially disadvantaged families (ie, maternal education of primary school level or lower) with at least one child younger than 36 months. Participants within communities were mother-child dyads, where the child was 12-36 months of age at enrollment, and the mother had low maternal education. In the parenting intervention group, participants attended 12 fortnightly peer-led group sessions focusing on child care and maternal wellbeing. The primary outcomes were cognitive and receptive language development, as measured with the Bayley Scales of Infant Development, 3rd edn. Secondary outcomes included self-reported maternal depressive symptoms, using the Center for Epidemiologic Studies Depression Scale, and child growth. Theoretically-relevant parenting practices, including the Home Observation for Measurement of the Environment inventory, and mother-care variables, such as perceived spousal support, were also assessed as potential mediators. Baseline assessments were done in January, 2013, and endline assessments were done in November, 2013, 3 months after completion of the programme. Ethics approval was received from Mbarara and McGill universities. This trial is registered with ClinicalTrials.gov, NCT01906606. Findings: Between December, 2012, and January, 2013, 13 communities (194 dyads) were randomly assigned to receive intervention, and 12 communities (154 dyads) were assigned to a waitlist control. 319 dyads completed baseline measures (171 in the intervention group and 148 in the control group), and 291 dyads completed endline measures (160 in the intervention group and 131 in the control group). At endline, children in the intervention group had significantly higher cognitive scores (58·90 vs 55·65, effect size 0·36, 95% CI 0·12-0·59) and receptive language scores (23·86 vs 22·40, 0·27, 0·03-0·50) than did children in the control group. Mothers in the intervention group reported significantly fewer depressive symptoms (15·36 vs 18·61, -0·391, 95% CI -0·62 to -0·16) than did mothers in the control group. However, no differences were found in child growth between groups. Interpretation: The 12 session integrated parenting intervention delivered by non-professional community members improved child development and maternal wellbeing in rural Uganda. Because this intervention was largely managed and implemented by a local organisation, using local community members and minimal resources, such a programme has the potential to be replicated and scaled up in other low-resource, village-based settings. Funding: Plan Uganda via Plan Finland (Ministry of Foreign Affairs) and Plan Australia (Australian Aid).

The Lancet. Global health · randomised controlled trial · 208 citationsread the source →

Empagliflozin in Heart Failure: Diuretic and Cardiorenal Effects.

Background: Sodium-glucose cotransporter-2 inhibitors improve heart failure-related outcomes. The mechanisms underlying these benefits are not well understood, but diuretic properties may contribute. Traditional diuretics such as furosemide induce substantial neurohormonal activation, contributing to the limited improvement in intravascular volume often seen with these agents. However, the proximal tubular site of action of the sodium-glucose cotransporter-2 inhibitors may help circumvent these limitations. Methods: Twenty patients with type 2 diabetes mellitus and chronic, stable heart failure completed a randomized, placebo-controlled crossover study of empagliflozin 10 mg daily versus placebo. Patients underwent an intensive 6-hour biospecimen collection and cardiorenal phenotyping at baseline and again after 14 days of study drug. After a 2-week washout, patients crossed over to the alternate therapy with the above protocol repeated. Results: Oral empagliflozin was rapidly absorbed as evidenced by a 27-fold increase in urinary glucose excretion by 3 hours (P<0.0001). Fractional excretion of sodium increased significantly with empagliflozin monotherapy versus placebo (fractional excretion of sodium, 1.2±0.7% versus 0.7±0.4%; P=0.001), and there was a synergistic effect in combination with bumetanide (fractional excretion of sodium, 5.8±2.5% versus 3.9±1.9%; P=0.001). At 14 days, the natriuretic effect of empagliflozin persisted, resulting in a reduction in blood volume (-208 mL [interquartile range, -536 to 153 mL] versus -14 mL [interquartile range, -282 to 335 mL]; P=0.035) and plasma volume (-138 mL, interquartile range, -379 to 154±453 mL; P=0.04). This natriuresis was not, however, associated with evidence of neurohormonal activation because the change in norepinephrine was superior (P=0.02) and all other neurohormones were similar (P<0.34) during the empagliflozin versus placebo period. Furthermore, there was no evidence of potassium wasting (P=0.20) or renal dysfunction (P>0.11 for all biomarkers), whereas both serum magnesium (P<0.001) and uric acid levels (P=0.008) improved. Conclusions: Empagliflozin causes significant natriuresis, particularly when combined with loop diuretics, resulting in an improvement in blood volume. However, off-target electrolyte wasting, renal dysfunction, and neurohormonal activation were not observed. This favorable diuretic profile may offer significant advantage in the management of volume status in patients with heart failure and may represent a mechanism contributing to the superior long-term heart failure outcomes observed with these agents. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03027960.

Circulation · randomised controlled trial · 322 citationsread the source →

Internet-based behavioural activation with lay counsellor support versus online minimal psychoeducation without support for treatment of depression: a randomised controlled trial in Indonesia.

Background: Depression is one of the leading contributors to the global burden of disease. However, treatment availability is often very poor in low-income and middle-income countries. In a randomised clinical trial, we investigated the efficacy of internet-based behavioural activation with lay counsellor support compared with online minimal psychoeducation without support for depression in Indonesia (a middle-income country). Methods: We did a community-based, two-group, randomised controlled trial in Indonesia. Eligible participants were aged 16 years or older, scored 10 or above on the Patient Health Questionnaire 9 (PHQ-9), met the criteria for major depressive disorder or persistent depressive disorder based on the Structured Clinical Interview for DSM-5, were proficient in Bahasa Indonesia, and could use the internet. Participants were randomly allocated (1:1) by a research assistant using a web-based randomisation program to online behavioural activation with lay support (termed Guided Act and Feel Indonesia [GAF-ID]) or online psychoeducation without further support. Randomisation was done within a random permuted block design and was stratified by sex and depression severity (ie, PHQ-9 10-14 vs ≥15). The primary outcome was self-reported PHQ-9 score at 10 weeks from baseline. Research assistants were masked to group allocation until after the assessment of the primary outcome. Interventions were described to participants during the consent procedure and after randomisation, but no indication was given as to which was the intervention of interest and which was the control. Analysis was by intention to treat. The trial was registered in the Netherlands Trial Register, number NTR5920. It is closed to new particpants, and follow-up has been completed. Findings: Between Sept 6, 2016, and May 1, 2017, 313 participants were enrolled and randomly assigned, 159 to the GAF-ID group and 154 to the online psychoeducation group. At 10 weeks, PHQ-9 scores were significantly lower in the GAF-ID group than in the online psychoeducation group (mean difference -1·26 points [95% CI -2·29 to -0·23]; p=0·017), and participants in the GAF-ID group had a 50% higher chance of remission at 10 weeks (relative risk 1·50 [95% CI 1·19 to 1·88]; p<0·0001). An effect size of 0·24 for the GAF-ID group compared with the control group at 10 weeks was sustained over time (effect size 0·24 at 3 months, and 0·27 at 6 months). No adverse events were reported in either group. Interpretation: To our knowledge, ours is the first adequately powered randomised clinical trial of an internet-based intervention for depression in a low-income or middle-income country. Online behavioural activation with lay counsellor support efficaciously reduced symptoms of depression, and could help to bridge the mental health gap in low-income and middle-income countries. Funding: Indonesia Endowment Fund for Education, University of Groningen.

The lancet. Psychiatry · randomised controlled trial · 66 citationsread the source →

Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial.

Question: What is the effectiveness of gym-based exercise versus home-based exercise with telephone follow-up amongst adults with chronic conditions who have completed a short-term exercise program supervised by a health professional? Design: A randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded outcome assessment at baseline and 3, 6, 9 and 12 months. Participants: The participants were recruited following a 6-week exercise program at a community health service. Intervention: One group of participants received a gym-based exercise program for 12 months (gym group). The other group received a home-based exercise program for 12 months with telephone follow-up for the first 10 weeks (home group). Outcome measures: Outcome measures included European Quality of Life Instrument (EQ-5D), the Friendship Scale, the Hospital and Anxiety and Depression Scale, Phone-FITT, 6-minute walk test, body mass index and 15-second sit-to-stand test. Results: There was no significant difference between study groups in the primary outcome (EQ-5D visual analogue scale, 0 to 100) across the 12-month intervention period, with an estimate (adjusted regression coefficient) of the difference in effects of 0 (95% CI -5 to 4). The gym group demonstrated slightly fewer symptoms of depression over the 12-month period compared to the home group (mean difference 0.8 points on a 21-point scale, 95% CI 0.1 to 1.6). Conclusion: Similar long-term clinical outcomes and long-term exercise adherence are achieved with the two approaches examined in this study. Participation in gym-based group exercise may improve mental health outcomes slightly more, although the mechanisms for this are unclear because there was no change in the selected measure of social isolation or other measures of health and wellbeing. This finding may also be a Type 1 error. Further research to reproduce these results and that investigates the economic efficiency of these models of care is indicated. Trial registration: ACTRN12610001035011. [Jansons P, Robins L, O'Brien L, Haines T (2017) Gym-based exercise and home-based exercise with telephone support have similar outcomes when used as maintenance programs in adults with chronic health conditions: a randomised trial. Journal of Physiotherapy 63: 154-160].

Journal of physiotherapy · randomised controlled trial · 24 citationsread the source →

Meditation or exercise for preventing acute respiratory infection: a randomized controlled trial.

Purpose: This study was designed to evaluate potential preventive effects of meditation or exercise on incidence, duration, and severity of acute respiratory infection (ARI) illness. Methods: Community-recruited adults aged 50 years and older were randomized to 1 of 3 study groups: 8-week training in mindfulness meditation, matched 8-week training in moderate-intensity sustained exercise, or observational control. The primary outcome was area-under-the-curve global illness severity during a single cold and influenza season, using the Wisconsin Upper Respiratory Symptom Survey (WURSS-24) to assess severity. Health care visits and days of missed work were counted. Nasal wash collected during ARI illness was assayed for neutrophils, interleukin-8, and viral nucleic acid. Results: Of 154 adults randomized into the study, 149 completed the trial (82% female, 94% white, mean age 59.3 ± 6.6 years). There were 27 ARI episodes and 257 days of ARI illness in the meditation group (n = 51), 26 episodes and 241 illness days in the exercise group (n = 47), and 40 episodes and 453 days in the control group (n = 51). Mean global severity was 144 for meditation, 248 for exercise, and 358 for control. Compared with control, global severity was significantly lower for meditation (P = .004). Both global severity and total days of illness (duration) trended toward being lower for the exercise group (P=.16 and P=.032, respectively), as did illness duration for the meditation group (P=.034). Adjusting for covariates using zero-inflated multivariate regression models gave similar results. There were 67 ARI-related days of-work missed in the control group, 32 in the exercise group (P = .041), and 16 in the meditation group (P <.001). Health care visits did not differ significantly. Viruses were identified in 54% of samples from meditation, 42% from exercise, and 54% from control groups. Neutrophil count and interleukin-8 levels were similar among intervention groups. Conclusions: Training in meditation or exercise may be effective in reducing ARI illness burden.

Annals of family medicine · randomised controlled trial · 91 citationsread the source →

The effect of low molecular weight heparin on survival in patients with advanced malignancy.

Purpose: Studies in cancer patients with venous thromboembolism suggested that low molecular weight heparin may prolong survival. In a double-blind study, we evaluated the effect of low molecular weight heparin on survival in patients with advanced malignancy without venous thromboembolism. Methods: Patients with metastasized or locally advanced solid tumors were randomly assigned to receive a 6-week course of subcutaneous nadroparin or placebo. The primary efficacy analysis was based on time from random assignment to death. The primary safety outcome was major bleeding. Results: In total, 148 patients were allocated to nadroparin and 154 patients were allocated to placebo. Mean follow-up was 1 year. In the intention-to-treat analysis the overall hazard ratio of mortality was 0.75 (95% CI, 0.59 to 0.96) with a median survival of 8.0 months in the nadroparin recipients versus 6.6 months in the placebo group. After adjustment for potential confounders, the treatment effect remained statistically significant. Major bleeding occurred in five (3%) of nadroparin-treated patients and in one (1%) of the placebo recipients (P = .12). In the a priori specified subgroup of patients with a life expectancy of 6 months or more at enrollment, the hazard ratio was 0.64 (95% CI, 0.45 to 0.90) with a median survival of 15.4 and 9.4 months, respectively. For patients with a shorter life expectancy, the hazard ratio was 0.88 (95% CI, 0.62 to 1.25). Conclusion: A brief course of subcutaneous low molecular weight heparin favorably influences the survival in patients with advanced malignancy and deserves additional clinical evaluation.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · randomised controlled trial · 401 citationsread the source →

The impact of advance care planning on end of life care in elderly patients: randomised controlled trial.

Objective: To investigate the impact of advance care planning on end of life care in elderly patients. Design: Prospective randomised controlled trial. Setting: Single centre study in a university hospital in Melbourne, Australia. Participants: 309 legally competent medical inpatients aged 80 or more and followed for six months or until death. Interventions: Participants were randomised to receive usual care or usual care plus facilitated advance care planning. Advance care planning aimed to assist patients to reflect on their goals, values, and beliefs; to consider future medical treatment preferences; to appoint a surrogate; and to document their wishes. Main outcome measures: The primary outcome was whether a patient's end of life wishes were known and respected. Other outcomes included patient and family satisfaction with hospital stay and levels of stress, anxiety, and depression in relatives of patients who died. Results: 154 of the 309 patients were randomised to advance care planning, 125 (81%) received advance care planning, and 108 (84%) expressed wishes or appointed a surrogate, or both. Of the 56 patients who died by six months, end of life wishes were much more likely to be known and followed in the intervention group (25/29, 86%) compared with the control group (8/27, 30%; P<0.001). In the intervention group, family members of patients who died had significantly less stress (intervention 5, control 15; P<0.001), anxiety (intervention 0, control 3; P=0.02), and depression (intervention 0, control 5; P=0.002) than those of the control patients. Patient and family satisfaction was higher in the intervention group. Conclusions: Advance care planning improves end of life care and patient and family satisfaction and reduces stress, anxiety, and depression in surviving relatives. Trial registration Australian New Zealand clinical trials registry ACTRN12608000539336.

BMJ (Clinical research ed.) · randomised controlled trial · 1481 citationsread the source →

Medicinal plants used in Jeddah, Saudi Arabia: A gender perspective.

Ethnopharmacological relevance: Very few studies examining quantitatively gender differences in the knowledge and use of medicinal plants exist for the Arab world. Differences in ethnobotanical knowledge of medicinal plants between men and women in Jeddah are explored here for the first time. Aim of the study: Our study aims to document urban medicinal plant knowledge in Jeddah, and to answer the following questions: (1) What medicinal plants are used by Saudis in Jeddah? (2) To what extent do men and women use medicinal plants? (3) Are plants used by men significantly different to those used by women? And, (4) do men and women learn about medicinal plants in different ways? Given the gendered nature of space and relations in the Arab world, we hypothesise that men and women learn about plants in different ways and that this will contribute to explain any possible differences. Materials and methods: Ethnobotanical fieldwork took place in Jeddah from August 2018 to September 2019. Individual free-listing, semi-structured interviews and an online survey questionnaire were carried out to document local medicinal plant. In total, 50 men and 50 women were interviewed face-to-face and 344 people responded to the questionnaire, of which 154 were men and 190 were women. Results: A total of 94 medicinal plant vernacular names were documented representing 85 different plant species belonging to 37 families. Men cited 63 plants (33 plant families) and women 83 (36 plant families). Sixty-one plants were cited by both men and women, two only by men and 22 only by women. Men and women learn in similar ways, but generally use medicinal plants to treat different ailments. Women rely on medicinal plant use to a larger extent. Conclusion: Medicinal plant use is dependent on gendered social roles and experience, as well as preference for biomedicine or medicinal plant use. Men and women use similar plants, but women have greater knowledge that increases with age. Given the food-medicine continuum, women's double role of family food and care providers may explain their expertise in medicinal plant use.

Journal of ethnopharmacology · cohort or longitudinal · 21 citationsread the source →

The beneficial effects of empagliflozin, an SGLT2 inhibitor, on atherosclerosis in ApoE -/- mice fed a western diet.

Aims/hypothesis: A recent large clinical study has shown that empagliflozin has a lower rate of cardiovascular and all-cause mortality when compared with placebo in patients with type 2 diabetes. We investigated the effect of empagliflozin (compared with glimepiride) on the progression of atherosclerosis, and its possible mechanisms of action. Methods: Forty-eight 5-week-old male ApoE -/- mice were fed a western diet for 20 weeks and divided into four groups: control (saline, 154 mmol/l NaCl), glimepiride 0.1 mg/kg, empagliflozin 1 mg/kg and empagliflozin 3 mg/kg (n = 12/group). Plaque size and composition in the aortic arch/valve areas and cardiovascular risk variables in the blood and tissues were evaluated. Insulin resistance was estimated by HOMA and adiponectin levels. Body composition was determined using dual-energy x-ray absorptiometry. Results: After 8 weeks of treatment, the empagliflozin and glimepiride groups exhibited decreased blood glucose levels. Atherosclerotic plaque areas in the aortic arch/valve were significantly smaller in the empagliflozin groups than in the control or glimepiride groups. Insulin resistance and circulating concentrations of TNF-α, IL-6, monocyte chemoattractant protein-1 (MCP-1), serum amyloid A and urinary microalbumin decreased after empagliflozin treatment, and this significantly correlated with plaque size. Empagliflozin treatment reduced weight and fat mass, lipid droplets in the liver, fat cell size, mRNA expression of Tnf, Il6 and Mcp-1 (also known as Ccl2) and the infiltration of inflammatory cells in plaque and adipose tissue compared with the control or glimepiride group. Empagliflozin treatment increased adiponectin levels. Conclusions/interpretation: Improvements in inflammation and insulin resistance seem to be mechanisms involved in the mitigation of atherosclerosis by empagliflozin.

Diabetologia · 213 citationsread the source →

Marital violence and coparenting quality after separation.

Research has identified multiple predictors of coparenting quality, but few studies have investigated how intimate partner violence (IPV) affects divorcing couples' coparenting relationships. We addressed this question in a sample of 154 mothers with different marital IPV experiences. Mothers were recruited within 4 months of a divorce filing and completed two interviews 3 months apart. At Time 1, mothers reported on violence and coercive control during marriage, and postseparation behavioral (e.g., parental communication), emotional (e.g., anger), and intrusion (e.g., harassment) dynamics; at Time 2, they reported on coparenting quality (i.e., levels of support and conflict). In the overall sample, divorce and violence variables independently predicted coparenting quality. Mothers were then classified into three groups: no violence (NV; n = 74), situational couple violence (SCV; n = 46), or coercive controlling violence (CCV; n = 34). Of the 3, coparenting quality was lowest in the CCV group. While the SCV group was similar to the NV group on most divorce-related variables, the CCV group reported more hostility at separation and placed less importance on father-child relationships. Finally, patterns of association between study variables and coparenting quality showed some parallels between the SCV and NV groups. For CCV, postseparation harassment and fear were negatively associated with coparenting quality. Findings contribute to understanding predictors of coparenting quality and support the need for individualized assessments of divorce cases with attention to IPV dynamics.

Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43) · 11 citationsread the source →

Measuring COVID-19-related fear and threat in Australian, Indian, and Nepali university students.

The present study describes the adaption and validation of a brief measure of contagion-related fear and threat in Australian, Indian, and Nepali university students in Australia at the height of the first wave of the COVID-19 pandemic. Adapted from Ho, Kwong-Lo, Mak, and Wong's (2005) SARS-related fear scale, the Contagion Fear and Threat Scale (CFTS) was rapidly adapted to capture the experience of COVID-19 pandemic-related fear. The factor structure and validity of the 6-item scale were established among Australian (n = 154), Indian (n = 111), and Nepali (n = 149) university students studying in Australia in May-June 2020. Factor analysis revealed two 3-item factors in the Australian student sample: Fear of Infection and Existential Threat. These factors were confirmed in the Indian and Nepali student samples and mirror those found by the Ho et al. (2005) in their original instrument. The convergent and discriminant validity of the full CFTS, Fear of Infection, and Existential Threat scales are indicated via correlations with established measures of depression, anxiety, stress, subjective wellbeing, and religiosity. Differences in the performance of the Fear of Infection and Existential Threat scales are considered in terms of the respective objective and subjective nature of the constructs.

Personality and individual differences · 6 citationsread the source →

Current Status and Influencing Factors of Self-management Positivity in Patients With Head and Neck Neoplasms: A Cross-sectional Study.

Background: Self-management positivity is important for patients to improve treatment outcomes, reduce healthcare costs, and provide an intrinsic motivation to gain hope and self-confidence in coping with their illness. In clinical practice, it has been found that head and neck cancer (HNC) patients have a lower level of self-management positivity. Objective: To investigate the degree of self-management positivity among patients with HNC and analyze its influencing factors. Methods: A cross-sectional survey of 215 patients in the radiotherapy department was conducted using the Patient Activation Measure 13 (PAM13), Health Literacy Management Scale, Acceptance of Illness Scale, Cancer Loneliness Scale, and General Self-efficacy Scale. Results: The PAM13 score of patients with HNC was 63.48 ± 14.7 at level 3. Multiple linear regression analysis showed that widowhood (β = -.127; P < .05), monthly family income per capita (β = .234; P < .01), disease duration (β = .154; P < .01), health literacy (β = .215; P < .01), loneliness (β = -.128; P < .05), disease acceptance (β = .144; P < .05), and self-efficacy (β = .152; P < .01) were the influencing factors of self-management positivity, which accounted for 37.9% of the total variance. Conclusion: Patients' self-management positivity still needs to be improved. Medical staff should attach great importance to patients' psychological dynamics and actively popularize health knowledge in order to effectively enhance self-management enthusiasm. Implications for practice: It is imperative that we give adequate attention to the self-management positivity of HNC patients. In addition, our country can try to incorporate PAM13 into the healthcare system, using the scale to identify patients who lack self-management awareness, knowledge, and ability and are at risk of readmission upon admission or discharge.

Cancer nursing · 1 citationsread the source →

Adolescents' Intense and Problematic Social Media Use and Their Well-Being in 29 Countries.

Purpose: This study examined (1) whether intense and problematic social media use (SMU) were independently associated with adolescent well-being; (2) whether these associations varied by the country-level prevalence of intense and problematic SMU; and (3) whether differences in the country-level prevalence of intense and problematic SMU were related to differences in mobile Internet access. Methods: Individual-level data came from 154,981 adolescents (meanage = 13.5) from 29 countries that participated in the 2017/2018 Health Behaviour in School-aged Children (HBSC) survey. Intense SMU was measured by the time spent on social media, whereas problematic SMU was defined by symptoms of addiction to social media. Mental (life satisfaction and psychological complaints), school (school satisfaction and perceived school pressure), and social (family support and friend support) well-being were assessed. Country-level data came from aggregated individual-level data and data from the Organisation for Economic Co-operation and Development (OECD) on Internet access. Results: Two-level regression analyses indicated that in countries with a lower prevalence of intense SMU, intense users reported lower levels of life satisfaction and family support and more psychological complaints than nonintense users. In contrast, in countries with a higher prevalence of intense SMU, intense users reported higher levels of family support and life satisfaction than nonintense users, and similar levels of psychological complaints. In all countries, intense users reported more friend support than nonintense users. The findings regarding problematic SMU were more consistent: In all countries, problematic users reported lower well-being on all domains than nonproblematic users. Observed differences in country-level prevalence rates of intense and problematic SMU could not be explained by mobile Internet access. Conclusions: Adolescents reporting problematic SMU are particularly at risk of lower well-being. In many countries, intense SMU may be a normative adolescent behavior that contributes positively to specific domains of their well-being.

The Journal of adolescent health : official publication of the Society for Adolescent Medicine · 175 citationsread the source →

Factors Driving Citizen Engagement With Government TikTok Accounts During the COVID-19 Pandemic: Model Development and Analysis.

Background: During the COVID-19 pandemic, growth in citizen engagement with social media platforms has enabled public health departments to accelerate and improve health information dissemination, developing transparency and trust between governments and citizens. In light of these benefits, it is imperative to learn the antecedents and underlying mechanisms for this to maintain and enhance engagement. Objective: The aim of this study is to determine the factors and influencing mechanisms related to citizen engagement with the TikTok account of the National Health Commission of China during the COVID-19 pandemic. Methods: Using a web crawler, 355 short videos were collected from the Healthy China account on TikTok (with more than 3 million followers throughout China), covering the period from January 21, 2020, to April 25, 2020. The title and video length, as well as the number of likes, shares, and comments were collected for each video. After classifying them using content analysis, a series of negative binomial regression analyses were completed. Results: Among the 355 videos, 154 (43.4%) related to guidance for clinicians, patients, and ordinary citizens, followed by information concerning the government's handling of the pandemic (n=100, 28.2%), the latest news about COVID-19 (n=61, 17.2%), and appreciation toward frontline emergency services (n=40, 11.3%). Video length, titles, dialogic loop, and content type all influenced the level of citizen engagement. Specifically, video length was negatively associated with the number of likes (incidence rate ratio [IRR]=0.19, P<.001) and comments (IRR=0.39, P<.001). Title length was positively related to the number of shares (IRR=24.25, P=.01), likes (IRR=8.50, P=.03), and comments (IRR=7.85, P=.02). Dialogic loop negatively predicted the number of shares (IRR=0.56, P=.03). In comparison to appreciative information, information about the government's handling of the situation (IRR=5.16, P<.001) and guidelines information (IRR=7.31, P<.001) were positively correlated with the number of shares, while the latest news was negatively related to the number of likes received (IRR=0.46, P=.004). More importantly, the relationship between predictors and citizen engagement was moderated by the emotional valence of video titles. Longer videos with positive titles received a higher number of likes (IRR=21.72, P=.04) and comments (IRR=10.14, P=.047). Furthermore, for short videos related to government handling of the pandemic (IRR=14.48, P=.04) and guidance for stakeholders (IRR=7.59, P=.04), positive titles received a greater number of shares. Videos related to the latest news (IRR=66.69, P=.04) received more likes if the video title displayed higher levels of positive emotion. Conclusions: During the COVID-19 pandemic, videos were frequently published on government social media platforms. Video length, title, dialogic loop, and content type significantly influenced the level of citizen engagement. These relationships were moderated by the emotional valence of the video's title. Our findings have implications for maintaining and enhancing citizen engagement via government social media.

Journal of medical Internet research · 46 citationsread the source →

Dissecting the Association Between Inflammation, Metabolic Dysregulation, and Specific Depressive Symptoms: A Genetic Correlation and 2-Sample Mendelian Randomization Study.

Importance: Observational studies highlight associations of C-reactive protein (CRP), a general marker of inflammation, and interleukin 6 (IL-6), a cytokine-stimulating CRP production, with individual depressive symptoms. However, it is unclear whether inflammatory activity is associated with individual depressive symptoms and to what extent metabolic dysregulation underlies the reported associations. Objective: To explore the genetic overlap and associations between inflammatory activity, metabolic dysregulation, and individual depressive symptoms. Gwas data sources: Genome-wide association study (GWAS) summary data of European individuals, including the following: CRP levels (204 402 individuals); 9 individual depressive symptoms (3 of which did not differentiate between underlying diametrically opposite symptoms [eg, insomnia and hypersomnia]) as measured with the Patient Health Questionnaire 9 (up to 117 907 individuals); summary statistics for major depression, including and excluding UK Biobank participants, resulting in sample sizes of 500 199 and up to 230 214 individuals, respectively; insomnia (up to 386 533 individuals); body mass index (BMI) (up to 322 154 individuals); and height (up to 253 280 individuals). Design: In this genetic correlation and 2-sample mendelian randomization (MR) study, linkage disequilibrium score (LDSC) regression was applied to infer single-nucleotide variant-based heritability and genetic correlation estimates. Two-sample MR tested potential causal associations of genetic variants associated with CRP levels, IL-6 signaling, and BMI with depressive symptoms. The study dates were November 2019 to April 2020. Results: Based on large GWAS data sources, genetic correlation analyses revealed consistent false discovery rate (FDR)-controlled associations (genetic correlation range, 0.152-0.362; FDR P = .006 to P < .001) between CRP levels and depressive symptoms that were similar in size to genetic correlations of BMI with depressive symptoms. Two-sample MR analyses suggested that genetic upregulation of IL-6 signaling was associated with suicidality (estimate [SE], 0.035 [0.010]; FDR plus Bonferroni correction P = .01), a finding that remained stable across statistical models and sensitivity analyses using alternative instrument selection strategies. Mendelian randomization analyses did not consistently show associations of higher CRP levels or IL-6 signaling with other depressive symptoms, but higher BMI was associated with anhedonia, tiredness, changes in appetite, and feelings of inadequacy. Conclusions and relevance: This study reports coheritability between CRP levels and individual depressive symptoms, which may result from the potentially causal association of metabolic dysregulation with anhedonia, tiredness, changes in appetite, and feelings of inadequacy. The study also found that IL-6 signaling is associated with suicidality. These findings may have clinical implications, highlighting the potential of anti-inflammatory approaches, especially IL-6 blockade, as a putative strategy for suicide prevention.

JAMA psychiatry · 228 citationsread the source →

Opening communication channels with people living with HIV using mobile phone text messaging: insights from the CAMPS trial.

Background: Using two-way mobile phone text messages to improve adherence to antiretroviral medication enhances communication between patients and health workers. We describe the implications of participants' responses to text messages in the Cameroon Mobile Phone SMS (CAMPS) trial. Findings: This is a cross-sectional analysis of data from the intervention arm of the CAMPS trial. CAMPS was a randomized controlled trial of motivational text messaging versus usual care to improve adherence to antiretroviral medication among people living with HIV in Yaounde, Cameroon (n = 200) over a 6 month period. Participants in the intervention arm (n = 101) were given a contact phone number, but were not required to respond to their reminder messages. If they did, their responses were noted and reported as counts and percentages. We received 99 phone calls and 55 text messages (154 responses) from 48 participants during the study period. The median number of responses was 1 (first quartile [Q1]: 1; third quartile [Q3]: 3). Half (n = 79, 51.1%) of them were expressions of gratitude. The rest included requests for logistical (n = 21, 13.6%), medical (n = 20, 12.9%) and financial (n = 11, 7.1%) support. Conclusion: Initiating two-way mobile communication opens more channels for people living with HIV to express unmet needs. Researchers, policy makers and clinicians should be ready to respond to the needs expressed by patients who respond to text messages. Trial registration: Pan-African Clinical Trials Registry: PACTR201011000261458;

BMC research notes · 19 citationsread the source →

Family connections: a program for preventing child neglect.

Family Connections was a demonstration program specifically designed to prevent child neglect. This article describes the development of prevention strategies and the assessment of outcomes for families who received two versions of the intervention. The sample included 154 families (473 children) in a poor, urban neighborhood who met risk criteria for child neglect and who were randomly assigned to receive either a 3- or 9-month intervention. Self-report and observational data were analyzed using analyses of variance (ANOVA) with repeated measures. Results for the entire sample indicated positive changes in protective factors (parenting attitudes, parenting competence, social support); diminished risk factors (parental depressive symptoms, parenting stress, life stress); and improved child safety (physical and psychological care of children) and behavior (decreased externalizing and internalizing behavior). Results further reflected no advantage of the 9-month intervention for improving parenting adequacy. Further testing of the intervention with other target populations is being conducted.

Child maltreatment · 35 citationsread the source →

A childhood obesity intervention developed by families for families: results from a pilot study.

Background: Ineffective family interventions for the prevention of childhood obesity have, in part, been attributed to the challenges of reaching and engaging parents. With a particular focus on parent engagement, this study utilized community-based participatory research to develop and pilot test a family-centered intervention for low-income families with preschool-aged children enrolled in Head Start. Methods: During year 1 (2009-2010), parents played an active and equal role with the research team in planning and conducting a community assessment and using the results to design a family-centered childhood obesity intervention. During year 2 (2010-2011), parents played a leading role in implementing the intervention and worked with the research team to evaluate its results using a pre-post cohort design. Intervention components included: (1) revisions to letters sent home to families reporting child body mass index (BMI); (2) a communication campaign to raise parents' awareness of their child's weight status; (3) the integration of nutrition counseling into Head Start family engagement activities; and (4) a 6-week parent-led program to strengthen parents' communication skills, conflict resolution, resource-related empowerment for healthy lifestyles, social networks, and media literacy. A total of 423 children ages 2-5 years, from five Head Start centers in upstate New York, and their families were exposed to the intervention and 154 families participated in its evaluation. Child outcome measures included BMI z-score, accelerometer-assessed physical activity, and dietary intake assessed using 24-hour recall. Parent outcomes included food-, physical activity- and media-related parenting practices and attitudes. Results: Compared with pre intervention, children at post intervention exhibited significant improvements in their rate of obesity, light physical activity, daily TV viewing, and dietary intake (energy and macronutrient intake). Trends were observed for BMI z-score, sedentary activity and moderate activity. Parents at post intervention reported significantly greater self-efficacy to promote healthy eating in children and increased support for children's physical activity. Dose effects were observed for most outcomes. Conclusions: Empowering parents to play an equal role in intervention design and implementation is a promising approach to family-centered obesity prevention and merits further testing in a larger trial with a rigorous research design.

The international journal of behavioral nutrition and physical activity · 114 citationsread the source →

The Personalized Advantage Index: translating research on prediction into individualized treatment recommendations. A demonstration.

Background: Advances in personalized medicine require the identification of variables that predict differential response to treatments as well as the development and refinement of methods to transform predictive information into actionable recommendations. Objective: To illustrate and test a new method for integrating predictive information to aid in treatment selection, using data from a randomized treatment comparison. Method: Data from a trial of antidepressant medications (N = 104) versus cognitive behavioral therapy (N = 50) for Major Depressive Disorder were used to produce predictions of post-treatment scores on the Hamilton Rating Scale for Depression (HRSD) in each of the two treatments for each of the 154 patients. The patient's own data were not used in the models that yielded these predictions. Five pre-randomization variables that predicted differential response (marital status, employment status, life events, comorbid personality disorder, and prior medication trials) were included in regression models, permitting the calculation of each patient's Personalized Advantage Index (PAI), in HRSD units. Results: For 60% of the sample a clinically meaningful advantage (PAI≥3) was predicted for one of the treatments, relative to the other. When these patients were divided into those randomly assigned to their "Optimal" treatment versus those assigned to their "Non-optimal" treatment, outcomes in the former group were superior (d = 0.58, 95% CI .17-1.01). Conclusions: This approach to treatment selection, implemented in the context of two equally effective treatments, yielded effects that, if obtained prospectively, would rival those routinely observed in comparisons of active versus control treatments.

PloS one · 287 citationsread the source →