Cluster Randomised Controlled Feasibility Study of HENRY; a Community Based Intervention Aimed at Reducing School Entry Obesity Rates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Number of centres recruited
研究概览
简要总结
Tackling obesity is a public health priority. Childhood obesity is of particular concern due to its impact on physiological and psychological health and likelihood of tracking into adulthood, with associated diseases and disorders and financial burden to the NHS. Once established, obesity is hard to treat. Therefore, prevention strategies aimed at children are essential.
This study aims to determine the feasibility of undertaking a full trial to evaluate the clinical effectiveness of the HENRY (Health, Exercise, Nutrition for the Really Young) programme in preventing childhood obesity. It is a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study aiming to recruit 120 parents from 12 Children's Centres.
HENRY (Health, Exercise, Nutrition for the Really Young) is an 8 week community based intervention delivered in settings such as Children's Centres, aimed at preventing childhood obesity by supporting families to make positive lifestyle changes. It is currently widely delivered across the UK. Preliminary data indicates that HENRY may be effective at reducing childhood obesity and improving family health, although a robust evaluation has not yet been conducted. A good deal of public money has already been used to develop and commission HENRY and it is essential to demonstrate clear benefits of the programme before further funding. This study will determine whether a definitive randomised controlled trial (RCT) of HENRY is feasible. 12 Children's Centres will be recruited from two local authorities. From these, half will be randomised to deliver HENRY programmes.
From the participating Children's Centres, 120 parents will be recruited. All participants will be asked to meet with a researcher twice in their home, 12 months apart. During the visit, parents will complete 4 questionnaires around diet and lifestyle. Height and weight measurements will also be taken from the parent (optional) and child (compulsory). The decision of whether a RCT is feasible will be based on whether it is possible to recruit local authorities, children's centres and parents to take part; ensure staff can be adequately trained to deliver programmes within specified timeframes; and whether proposed data can be adequately gathered.
详细描述
Background:
Childhood obesity impacts physiological and psychological health that tracks into adulthood; increasing risk of morbidity and mortality [1, 2]. It incurs significant costs on the UK economy, with an expected 7-fold increase in related NHS costs by 2020, and forecasted £2 billion annual spend by 2030[3]. Tackling obesity is a key NHS public health priority, with government strategies aimed at reversing the trend of rising childhood obesity levels to return to those of 2000. Whilst treating obesity remains a priority, there are compelling arguments to prevent its onset. Establishing healthy behaviours in early childhood is critical for optimum growth and development [4]. Further, poor eating patterns developed early can persist and are associated with chronic diseases in adulthood (e.g. cardiovascular disease, type-2-diabetes [5]). Once established, obesity is difficult to reverse[6]; strengthening the case for primary prevention[7]. Early preventive interventions are therefore essential to impact the health of our children now and in the future [8].
Interventions aimed at treating obesity report inconsistent results [9-11, 6, 12, 13], though there is agreement that multi-component interventions, especially those engaging parents have a greater impact [14, 6]. Proposed research involves an independent evaluation of an existing preschool obesity prevention intervention. The HENRY programme was developed in 2007 with Department of Health and Department for Education support and is currently delivered across the UK by approximately 35 Local Authorities providing ~190 courses/year. Over 10,000 families have already participated. It is delivered in the community, predominantly by Children's Centre staff [15]. HENRY uses a responsive approach to provide practical guidance and improve parenting skills, aimed at enhancing family homes and Children's Centre environments. These are intervention targets that are consistent with recent literature in childhood obesity. Preliminary data indicates that HENRY may be effective at reducing childhood obesity and improving family health [15] although evidence to date has not compared findings with parents who have not attended HENRY; thus, further robust evaluation using a RCT design is needed to confirm its effectiveness. A good deal of public money has already been used to develop and commission HENRY and it is essential to demonstrate clear benefits of the programme before further funding. Given the uncertainties associated with recruiting local authorities, service providers and Children's Centres, it is necessary to conduct research in advance of a definitive multi-site trial. The models of commissioning and delivering HENRY are complex and vary by location. In some instance, HENRY is commissioned by local authorities and delivered by existing Centre staff. In others, Children's Centres are tendered to external service providers (e.g. Barnardo's) who are responsible for commissioning programmes such as HENRY. This study will assess feasibility of the planned recruitment rate at the authority, Centre and parent level and ensure competence of programme delivery; in addition to providing vital information for calculation of the sample size for the future trial. A future trial will be used to offer commissioners an evidence based intervention, tested in Children's Centres in the UK and to provide much needed evidence on the effectiveness of early obesity prevention in primary care settings.
Aim:
The feasibility study aims to determine the feasibility of undertaking a full trial to evaluate the clinical effectiveness of the HENRY programme in preventing childhood obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Treatment allocation will be withheld from research staff collecting the data. Screening forms will not indicate whether they have been recruited from active or control Centres The chief investigator, trial coordinator and statistician will not be provided details of treatment allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •SITE level Local authorities (or other associations that commission HENRY in Children's Centres), Children's Centres and parents meeting all of the relevant inclusion criteria, and none of the relevant exclusion criteria, will be considered for participation in the study.
- •Local authorities (and service providers if applicable):
- •Local Authorities must nominate a minimum of 6 Children's Centres and formally agree to allow randomisation of the Centres. Where possible, Centres should be in geographically separate areas to protect against contamination (judged on a case by case basis). Local authorities using external teams outside of the Centre to deliver HENRY programmes (e.g. health visitors) will be eligible, in addition to those wishing to train internal Centre staff to deliver programmes (the most common model currently used).
- •Included local authorities may be completely new to HENRY (having never trained or delivered HENRY) or contain at least 6 Centres that are within HENRY 'naïve' clusters. Clusters are defined as a number of Children's Centres that are close to each other or grouped for management purposes. HENRY naive clusters are:
- •A group of Centres within a cluster that do not include any Centres that are (a) currently delivering HENRY or (b) have been trained to, or delivered HENRY within the past 2 years.
- •PARENT level The target population for the intervention are parents of preschool children; mothers, fathers and carers (e.g. with children living in stable /long-term foster care).
- •Parents must have at least 1 child aged 6 months - 5 years (18 months-6 years at follow-up). If more than one child in the family fulfils eligibility criteria, the youngest child (by birth timing if twins) will be considered as the reference child (from which data will be collected).
- •Parents must be willing to attend the programme sessions (intervention Centres) and willing to provide data in accordance with the data collection protocol. Parents will be provided with full details of the data collection requirements in advance so that they can make informed decisions as to whether to participate.
- •Parents must speak English, unless they wish to bring their own interpreter with them (e.g. family member) (the intervention and data collection forms are currently only available in English).
排除标准
- •- SITE level
- •Children's Centres that have delivered HENRY programmes within the last 2 years or where staff have received HENRY training within the last 2 years.
- •PARENT level
- •Parents with severe learning difficulties that preclude them taking part in group sessions in which they need to be able to read and write, judged on a case by case basis with consultation with the HENRY team where appropriate.
- •Parents whose reference child is tube fed (PEG or nasogastric) or with other known clinical conditions likely to affect growth over the period of the trial (e.g. cancer, coeliac disease, or renal or cardiac problems). A detailed list of excluded conditions will be provided at screening, with any uncertainties resolved via clinical input from the HENRY team.
- •Parents who have attended a HENRY group for a previous child.
结局指标
主要结局
Number of centres recruited
时间窗: 12 months from ethical approval
Quality assurance in training achieved
时间窗: 12 months from ethical approval
Pass/fail of training completion recorded by central HENRY team
Number of parents recruited per centre
时间窗: 12 months from completion of training
Intervention fidelity
时间窗: 24 months from completion of training
Adherence to manual identified through observations of intervention sessions
Contamination risk score
时间窗: 24 months from completion of training
Qualitatively assessed and assigned score. Combined risk probability and risk severity scores. Risk probability assessed with a 5-point ordinal scale, ranging from 1 (improbable frequency of risk) to 5 (frequent). Risk severity assessed with a 5-point ordinal scale ranging from A (severe likelihood that contamination will impact on the trial) to E (negligible impact). Combined responses mean that there are 25 possible responses with 5A representing greatest impact of contamination (Frequent and severe) to 1E (improbable contamination with negligible impact).
次要结局
- Reference child BMI z-score data(Measured at follow-up (12 months from parent recruitment))
- Trial acceptability qualitatively assessed through interviews with participants(24 months from centre recruitment)
研究者
Maria Bryant
Portfolio lead for Diet, Obesity and Lifestyle
University of Leeds
