Study design

Cultural adaptation of an existing children’s weight management programme: the CHANGE intervention and feasibility RCT · Study design

Study design

Aims and objectives

Study aims

The CHANGE study was designed in two phases. In the first phase, we aimed to adapt a weight management programme for children aged 4–11 years and their families, and to make it culturally relevant to Pakistani and Bangladeshi communities but also appropriate for families from all communities. In the second phase, we aimed to undertake a feasibility study of the culturally adapted intervention programme, using a cluster randomised design to compare the culturally adapted programme with the standard weight management programme.

Phase I objectives

To explore factors that promote or discourage engagement with, and completion of, existing childhood obesity treatment programmes among Pakistani and Bangladeshi families in the UK.
To use this information, together with existing research evidence and theoretical frameworks for cultural adaptation and complex intervention development, to design a theoretically informed childhood obesity treatment programme that is appropriate for all families but is culturally adapted to meet the particular needs of Pakistani and Bangladeshi families.

Phase II objectives

To assess the proportion of Pakistani and Bangladeshi families and the proportion of all families completing the adapted programme.
To assess the acceptability of the programme to Pakistani and Bangladeshi families and families from other ethnic groups.
To assess the feasibility of delivery of the adapted programme.
To assess the feasibility of participant recruitment, randomisation and follow-up.
To assess the feasibility of the collection of cost data from both a health and societal perspective to inform a future trial that evaluates intervention clinical effectiveness and cost-effectiveness.
To collect data on recruitment, attrition and other relevant measures to inform the parameters of any future trial.

Design and setting

The first phase addressed the theoretical and modelling stages of the UK Medical Research Council’s framework for the development and evaluation of complex health interventions.41,42 It involved adaptation of the current children’s weight management programme delivered in Birmingham, UK (First Steps). The adaptation process was informed by research evidence relating to the clinical effectiveness of childhood obesity treatment programmes and the experiences and view points of Pakistani and Bangladeshi families who had participated, or initially agreed but then declined to participate, in the current programme. The intervention adaptation process was guided by theoretical frameworks for complex intervention development and for adaptation of health promotion programmes for minority ethnic groups.35,43 The second phase addressed the feasibility stage of the Medical Research Council’s complex health intervention framework. We conducted a two-arm cluster randomised feasibility study that compared the culturally adapted programme with the existing programme. Programmes were randomised to be delivered as either the adapted or the standard programme in a 2 : 1 ratio. This ratio was used to ensure that there were a sufficient number of families in the intervention arm to enable calculation of the primary outcome of the proportion of Pakistani and Bangladeshi families completing the adapted programme. Data were collected from participants at three time points: before programme attendance, after programme completion and 6 months after programme completion. The study design is summarised in Figure 1.

FIGURE 1 The CHANGE study flow chart: study design and participants. a, Participants are blind to the allocation of the programme that they are attending. BP, Bangladeshi or Pakistani; FG, focus group. (Figure not reproduced here; see the original article.)

The study took place in Birmingham, which is the UK’s second largest city and has a population of nearly 1.1 million. Of this population, 16.5% are from Pakistani and Bangladeshi communities. Pakistani and Bangladeshi children constitute 26% of the Birmingham population that is aged 0–15 years.37

At the time of the study, all families resident in Birmingham with a child aged 4–11 years who had a BMI over the 91st centile of the UK’s 1990 growth reference charts44 were eligible to attend the First Steps children’s weight management programme (the programme that was adapted in this study). First Steps was commissioned by Birmingham City Council and delivered by Birmingham Community Healthcare NHS Trust (BCHCT). Children could be referred to the programme through several different routes: via health professionals, schools, the NCMP or self-referral. First Steps was a group-based programme delivered as weekly 1-hour sessions over 5–7 weeks in community venues. Session content included nutrition education, physical activity promotion and the promotion of positive lifestyle behaviour changes. The programme was aimed at parents/carers and children attended only the first and last sessions, at which their height and weight were measured. Participants for both phases of the study were identified through the existing children’s weight management services in Birmingham.

Public and patient involvement

A panel of parents of primary school-aged children from Bangladeshi and Pakistani communities was convened for the duration of the study. The Parent Advisory Panel was consulted at specific stages of the study to enable them to bring their values to the project and ensure that the development of the programme, outcome measures and research procedures were culturally appropriate. Input from the panel was sought for the planning of the qualitative studies in both phases I and II, the adapted intervention design, the planning of data collection procedures in the phase II feasibility study, the plans for disseminating the study findings and the preparation of the Plain English summary of the report. There was also a public member of the Study Steering Committee from the Pakistani community in Birmingham.

Study management

The study was overseen by an externally appointed, independent Study Steering Committee comprising three subject experts (two public health specialists with an interest in childhood obesity prevention and management and an expert on equality and diversity in relation to health and social care) and a public representative. A study management group, comprising the principal investigator, the study co-ordinator and two co-investigators, met regularly to guide the conduct of the study.

Ethics approval and study registration

Ethics approval was obtained in July 2014 from Edgbaston NHS Research Ethics Committee, West Midlands, UK (reference number 14/WM/1036). The study was registered with the International Standard Randomised Controlled Trial Register as reference number ISRCTN81798055. The original study protocol was sent to and was approved by the National Institute for Health Research (NIHR) Health Technology Assessment programme on 31 July 2014. A number of revisions and additions were made to the protocol during the course of the study and these are shown in Appendix 1. The final protocol was published as a journal article in 2016.45

Attribution. Miranda Pallan; Tania Griffin; Kiya L Hurley; Emma Lancashire; Jacqueline Blissett; Emma Frew et al. (2019). Cultural adaptation of an existing children’s weight management programme: the CHANGE intervention and feasibility RCT. NIHR Journals Library. Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Pallan et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Licensed under CC BY 4.0. NCBI Bookshelf NBK543481. CC BY 4.0. Original source ↗. Text reproduced from the Bookshelf XML without changing wording; figures, images and supplements are not reproduced.