Cultural adaptation of an existing children's weight management programme: the CHANGE intervention and feasibility RCT

Background: Excess weight in children is a continuing health issue. Community-based children’s weight management programmes have had some effect in promoting weight loss. Families from minority ethnic communities are less likely to complete programmes, but to date no programmes have been culturally adapted to address this.

Objectives: We aimed to: 1) culturally adapt an existing weight management programme for children aged 4-11 years and their families to be more suited to Pakistani and Bangladeshi communities but inclusive of all families; and 2) evaluate the adapted programme to assess its feasibility and acceptability, and the feasibility of methods for a future full-scale trial.

Design: Phase 1: cultural adaptation of a programme, informed by formative research and guided by two theoretical frameworks. Phase 2: a cluster-randomised feasibility study (clusters=children's weight management programmes).

Setting: Birmingham; a large, ethnically diverse UK city.

Participants: Phase 1: Pakistani and Bangladeshi parents of children with excess weight. Phase 2: children aged 4-11 years with excess weight and their families.Interventions: A culturally adapted children’s weight management programme, comprising six sessions, delivered to children and parents, targeting diet and physical activity, and incorporating behaviour change techniques was developed in phase 1 and delivered in the intervention arm to 16 groups in phase 2. The eight groups in the comparator arm received the standard (un-adapted) children's weight management programme.

Feasibility study outcome measures: The primary outcome was the proportion of Pakistani and Bangladeshi families completing (attending >60%) the adapted programme. Secondary outcomes included: proportion of all families completing the adapted programme; feasibility of delivery of the programme and acceptability to participants; feasibility of trial processes; and feasibility of collection of outcome and cost data.

Feasibility study results: The proportion of Pakistani and Bangladeshi families and all families completing the adapted programme was 78.8% (95% CI: 64.8-88.2%) and 76.3% (95% CI: 67.0-83.6%) respectively. The programme was feasible to deliver with some refinements and was well received. Ninety-two families participated in outcome data collection. Data collection was mostly feasible but participant burden was high. Data collection on cost of programme delivery was feasible but costs to families were more challenging to capture. There was high attrition over the 6 month follow up period (35%) and differential attrition in the two study arms (29% and 52% in intervention and comparator arms, respectively).

Limitations: The study was not designed to address the issue of low participant uptake of children's weight management programmes. The design of a future trial may include individual randomisation and a 'minimal intervention' arm, the acceptability of which has not been evaluated in this study.

Conclusions: The theoretically informed, culturally adapted children’s weight management programme was highly acceptable to children and families of all ethnicities. Consideration should be given to a future trial to evaluate clinical and cost-effectiveness of the adapted programme, but the design of a future trial would need to address the logistics of data collection, participant burden and study attrition.

Study registration: May 2014; ISRCTN81798055.Funding: National Institute for Health Research Health Technology Assessment Programme (12/137/05).