Robertson, Wendy, Stewart-Brown, Sarah L., Stallard, Nigel, Petrou, Stavros, Griffiths, Frances, Thorogood, Margaret, Simkiss, Douglas E., Lang, R. (Rebecca), Reddington, Kate, Poole, Francine, Rye, G. (Gloria), Khan, Kamran, Hamborg, Thomas and Kirby, J. (Joanna) (2013) Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity : study protocol for a randomized controlled trial. Trials, Volume 14 (Number 1). Article : 81. doi:10.1186/1745-6215-14-81 ISSN 1745-6215.
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Abstract
Background:
Effective programs to help children manage their weight are required. Families for Health focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base.
Methods/design:
This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton).
Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality.
A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children’s BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children’s waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents’ BMI and mental well-being, family eating/activity, parent–child relationships and parenting style will also be assessed.
Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.
Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made.
Discussion:
This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation.
Trial registration: Current Controlled Trials ISRCTN45032201
| Item Type: | Journal Article |
|---|---|
| Subjects: | R Medicine > RA Public aspects of medicine R Medicine > RJ Pediatrics > RJ101 Child Health. Child health services |
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Social Science & Systems in Health (SSSH) |
| Library of Congress Subject Headings (LCSH): | Obesity -- Research, Obesity in children -- Great Britain, Obesity in children -- Treatment, Medical care, Cost of |
| Journal or Publication Title: | Trials |
| Publisher: | Biomed Central |
| ISSN: | 1745-6215 |
| Official Date: | 2013 |
| Dates: | Date Event 2013 Published |
| Volume: | Volume 14 |
| Number: | Number 1 |
| Page Range: | Article : 81 |
| DOI: | 10.1186/1745-6215-14-81 |
| Status: | Peer Reviewed |
| Publication Status: | Published |
| Access rights to Published version: | Restricted or Subscription Access |
| Date of first compliant deposit: | 24 December 2015 |
| Date of first compliant Open Access: | 24 December 2015 |
| Funder: | NIHR Health Technology Assessment Programme (Great Britain), Great Britain. Dept. of Health (DoH) |
| Grant number: | 09/127/41 (NIHR HTA) |
| URI: | https://wrap.warwick.ac.uk/53979/ |
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