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Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design.

ABSTRACT: INTRODUCTION:Family-based behavioural weight management interventions are efficacious and widely used to address childhood obesity. Curriculum and strategies vary extensively and scale-up often depends on ensuring that the intervention fits the adoption context. AIMS AND OBJECTIVES:To evaluate the impact and implementation of a 'made in British Columbia' (BC) family-based early intervention programme (EIP) for 8-12?years old with overweight and obesity and their families. METHODS AND ANALYSIS:A randomised waitlist-control trial will assess a 10-week interactive, family-based lifestyle intervention followed by four maintenance sessions, in BC, Canada. We aim to enrol 186 families. The blended intervention includes at least 26 contact hours between participants and programme providers, including interactive activities and educational materials through weekly 90-min group sessions, an online family portal, and self-directed family activities. Curricular content includes information and activities related to healthy eating, physical activity (PA), positive mental health, parenting practices and sleep hygiene. The waitlist control group will receive a modified programme with the same 10-week sessions in the family portal, and four group sessions. Families participate in data collection at baseline, postintervention (week 10) and follow-up (week 18). The primary outcome is to assess changes in child body mass index z-score at 10?weeks between the groups. Secondary outcomes include changes at 10?weeks between the groups in child and parent PA behaviour and skills, healthy eating behaviour, and mental health. Process evaluation will address reach, implementation and maintenance (baseline, 10-week and 18-week) using recruitment tracking forms, parent questionnaire, programme attendance tracking forms, leader feedback surveys, parents and children satisfaction surveys and postprogramme interviews with facilitators, stakeholders and parents. Intention-to-treat analyses will be conducted. Process evaluation will be analysed thematically. ETHICS AND DISSEMINATION:Study procedures were designed to address research and community needs and will follow ethical standards. TRIAL REGISTRATION NUMBER:NCT03643341.

SUBMITTER: Liu S

PROVIDER: S-EPMC6830831 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design.

Liu Sam S Marques Isabela Gouveia IG Perdew Megan A MA Strange Karen K Hartrick Teresa T Weismiller Joy J Ball Geoff D C GDC Mâsse Louise C LC Rhodes Ryan R Naylor Patti-Jean PJ

BMJ open 20191031 10

<h4>Introduction</h4>Family-based behavioural weight management interventions are efficacious and widely used to address childhood obesity. Curriculum and strategies vary extensively and scale-up often depends on ensuring that the intervention fits the adoption context.<h4>Aims and objectives</h4>To evaluate the impact and implementation of a 'made in British Columbia' (BC) family-based early intervention programme (EIP) for 8-12 years old with overweight and obesity and their families.<h4>Metho ...[more]

PMID: 31676642

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Project description:Background and aims: Youth populations with overweight/obesity (OW/OB) exhibit heterogeneity in cardiometabolic health phenotypes (e.g. fasting glucose, serum triglycerides, etc.). The underling mechanisms for those differences are still unclear. This study aimed to analyze the whole blood transcriptome profile (RNA-seq) of children with metabolic healthy overweight/obesity (MHO) and metabolic unhealthy overweight/obesity (MUO) phenotypes. Methods: 27 children with OW/OB (10.14 ± 1.3 years, 59% boys) from the ActiveBrains project were included. MHO was defined as having none of the following criteria for metabolic syndrome: elevated fasting glucose, high serum triglycerides, low high-density lipoprotein cholesterol, and high systolic or diastolic blood pressure, while MUO was defined as presenting one or more of these criteria. Inflammatory markers interleukin-1β (IL-1β), IL-6, tumor necrosis factor-α (TNF-α), epidermal growth factor (EGF) and, vascular endothelial growth factor A (VEGF) were additionally determined. Total-blood RNA was analyzed by 5’-end RNA sequencing. Two different bioinformatics approaches were performed: 1) Differential gene expression analyses using Limma R/Bioconductor software package (analyses adjusted by sex and maturational status) and 2) weighted gene coexpression network analyses (WGCNA). Results: Children with MHO had lower values of pro-inflammatory cytokines TNF-α and IL-6 compared to MUO (p < 0.05). 40 genes were differentially expressed (FDR < 0.05) in children with MHO compared to MUO. WGCNA analysis identified 23 gene coexpression modules (i.e. clusters of genes) with low preservation (Zsummary < 2) in children with MHO compared to MUO. Differential and WGCNA gene expression patterns identified 32 genes linked to metabolism, mitochondrial and immune functions. Conclusions: Whole blood transcriptome analysis revealed a distinct pattern of gene expression in children with MHO compared to MUO children. The identified gene expression patterns related to metabolism, mitochondrial and immune functions can promote a better understanding of cardiovascular disease prognosis in individuals with MHO.

Project description:BackgroundAlthough literature provides support for cognitive behavioral therapy (CBT) as an efficacious intervention for social phobia, more research is needed to improve treatments for children.MethodsForty four Caucasian children (ages 8-14) meeting diagnostic criteria of social phobia according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA, 1994) were randomly allocated to either a newly developed CBT program focusing on cognition according to the model of Clark and Wells (n = 21) or a wait-list control group (n = 23). The primary outcome measure was clinical improvement. Secondary outcomes included improvements in anxiety coping, dysfunctional cognitions, interaction frequency and comorbid symptoms. Outcome measures included child report and clinican completed measures as well as a diagnostic interview.ResultsSignificant differences between treatment participants (4 dropouts) and controls (2 dropouts) were observed at post test on the German version of the Social Phobia and Anxiety Inventory for Children. Furthermore, in the treatment group, significantly more children were free of diagnosis than in wait-list group at post-test. Additional child completed and clinician completed measures support the results.DiscussionThe study is a first step towards investigating whether CBT focusing on cognition is efficacious in treating children with social phobia. Future research will need to compare this treatment to an active treatment group. There remain the questions of whether the effect of the treatment is specific to the disorder and whether the underlying theoretical model is adequate.ConclusionPreliminary support is provided for the efficacy of the cognitive behavioral treatment focusing on cognition in socially phobic children. Active comparators should be established with other evidence-based CBT programs for anxiety disorders, which differ significantly in their dosage and type of cognitive interventions from those of the manual under evaluation (e.g. Coping Cat).

Project description:BACKGROUND:Recent evidence shows that sport settings can act as a powerful draw to engage men in weight loss. The primary objective of this pilot study was to test the feasibility of delivering and to evaluate preliminary efficacy of Aussie-FIT, a weight-loss program for men with overweight/obesity delivered in Australian Football League (AFL) settings, in preparation for a future definitive trial. METHODS AND FINDINGS:This 6-month pilot trial took place in Perth, Australia. Participants were overweight/obese (Body Mass Index [BMI] ? 28 kg/m2), middle-aged (35-65 years old) men. Participants were recruited in May 2018, and the intervention took place between June and December 2018. The intervention involved 12 weekly 90-min face-to-face sessions, incorporating physical activity, nutrition, and behaviour change information and practical activities delivered by coaches at 2 clubs. Data were collected at baseline and immediately postintervention. For trial feasibility purposes, 6-month follow-ups were completed. Outcomes were differences in weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure at 3 months. Within 3 days of advertising at each club, 426 men registered interest; 306 (72%) were eligible. Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87) and randomised by a blinded researcher. Trial retention was 86% and 63% at 3- and 6-month follow-ups (respectively). No adverse events were reported. At 3 months, mean difference in weight between groups, adjusted for baseline weight and group, was 3.3 kg (95% CI 1.9, 4.8) in favour of the intervention group (p < 0.001). The intervention group's moderate-to-vigorous physical activity (MVPA) was higher than the control group by 8.54 min/day (95% CI 1.37, 15.71, p = 0.02). MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement. CONCLUSIONS:Aussie-FIT was feasible to deliver; participants increased physical activity, decreased weight, and reported improvements in other outcomes. Issues with retention were a limitation of this trial. In a future, fully powered randomised controlled trial (RCT), retention could be improved by conducting assessments outside of holiday seasons. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.

Project description:ObjectivesThe Solution Focused Brief Therapy in Post-Stroke Aphasia feasibility trial had four primary aims: to assess (1) acceptability of the intervention to people with aphasia, including severe aphasia, (2) feasibility of recruitment and retention, (3) acceptability of research procedures and outcome measures, and (4) feasibility of delivering the intervention by speech and language therapists.DesignTwo-group randomised controlled feasibility trial with wait-list design, blinded outcome assessors and nested qualitative research.SettingParticipants identified via two community NHS Speech and Language Therapy London services and through community routes (eg, voluntary-sector stroke groups).ParticipantsPeople with aphasia at least 6 months post stroke.InterventionSolution-focused brief therapy, a psychological intervention, adapted to be linguistically accessible. Participants offered up to six sessions over 3 months, either immediately postrandomisation or after a delay of 6 months.Outcome measuresPrimary endpoints related to feasibility and acceptability. Clinical outcomes were collected at baseline, 3 and 6 months postrandomisation, and at 9 months (wait-list group only). The candidate primary outcome measure was the Warwick-Edinburgh Mental Well-being Scale. Participants and therapists also took part in in-depth interviews.ResultsThirty-two participants were recruited, including 43.8% with severe aphasia. Acceptability endpoints: therapy was perceived as valuable and acceptable by both participants (n=30 interviews) and therapists (n=3 interviews); 93.8% of participants had ≥2 therapy sessions (90.6% had 6/6 sessions). Feasibility endpoints: recruitment target was reached within the prespecified 13-month recruitment window; 82.1% of eligible participants consented; 96.9% were followed up at 6 months; missing data <0.01%. All five prespecified feasibility progression criteria were met.ConclusionThe high retention and adherence rates, alongside the qualitative data, suggest the study design was feasible and therapy approach acceptable even to people with severe aphasia. These results indicate a definitive randomised controlled trial of the intervention would be feasible.Trial registration numberNCT03245060.

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Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design.

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Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design.

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