Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Cluster Randomised Controlled Feasibility Study of HENRY; a Community Based Intervention Aimed at Reducing School Entry Obesity Rates
Brief Summary: 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.


Options:
A: Arm Label: Intervention arm; Type: EXPERIMENTAL; Interventions: Behavioral: Healthy Start | Arm Label: Control arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Healthy Start; Assigned to Arm(s): Intervention arm
B: Arm Label: Usual Head Start Exposure; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Parents of Preschoolers Series (POPS); Type: EXPERIMENTAL; Interventions: Behavioral: Parents of Preschoolers Series | Arm Label: POPS + Incredible Years Series (IYS); Type: EXPERIMENTAL; Interventions: Behavioral: Parents of Preschoolers Series, Behavioral: Incredible Years Series | Intervention Type: BEHAVIORAL; Name: Parents of Preschoolers Series; Assigned to Arm(s): POPS + Incredible Years Series (IYS), Parents of Preschoolers Series (POPS) | Intervention Type: BEHAVIORAL; Name: Incredible Years Series; Assigned to Arm(s): POPS + Incredible Years Series (IYS)
C: Arm Label: HENRY; Type: EXPERIMENTAL; Interventions: Behavioral: HENRY | Arm Label: Waiting list control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: HENRY; Assigned to Arm(s): HENRY
D: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Parents Connect for Healthy Living (PConnect), Behavioral: Enhanced Nutrition Support, Behavioral: Media Resources | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Parents Connect for Healthy Living (PConnect); Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Enhanced Nutrition Support; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Media Resources; Assigned to Arm(s): Intervention

Answer: C