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

Joanna Kirby¹  Thomas Hamborg¹  Kamran A Khan¹  Gloria Rye⁴  Fran Poole²  Kate Reddington³  Rebecca Lang¹  Douglas Simkiss¹  Margaret Thorogood¹  Frances Griffiths¹  Stavros Petrou¹  Nigel Stallard¹  Sarah Stewart-Brown¹  Wendy Robertson¹ 

[1] Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK;Public Health Department, NHS Warwickshire, PO Box 43, Shire Hall, Barrack Street, Warwick, CV34 4SX, UK;Public Health, NHS Coventry, Civic Centre 1, Little Park Street, Coventry, CV1 5RB, UK;Wolverhampton City Council, Civic Centre, St Peter’s Square, Wolverhampton, WV1 1RT, UK

关键词: Economic evaluation;    Randomized controlled trial;    Parenting;    Weight management;    Childhood obesity;   

Others  :  1094486
DOI  :  10.1186/1745-6215-14-81

 received in 2012-12-19, accepted in 2013-03-08,  发布年份 2013

【 摘 要 】

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 http://ISRCTN45032201 webcite

【 授权许可】

   
2013 Robertson et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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