Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* 1) child age between 4 and 6 years
* 2) child BMI ≥5th %ile (Children below this BMI percentile may have an underlying biological mechanism that influences eating behaviors.)
* 3) active parental consent

Exclusion Criteria:

* 1) child with major psychological diagnosis, developmental delay, or other medical disorder that affects weight, eating behaviors, and cognition
* 2) food allergies to the foods used in the study
* 3) plans to leave the preschool within the timeframe of the study
B: Inclusion Criteria:

Fifteen preschools comparable in characteristics related to socio-economic level and ethnicity with the following criteria:

* The schools must be located in Harlem, NY;
* The schools must be public;
* The schools must have children 3, 4 and 5 years of age;
* The schools must provide meals for the children.
* The schools must make available use of their applicable program operation space.

Exclusion Criteria:

* Participation in any other major structured health intervention program similar to the FAMILIA Program during the evaluation of the program
* Inability to carry out all activities proposed by the FAMILIA Program
C: Inclusion Criteria:

* 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).

Exclusion Criteria:

* - 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.
D: Primary Outcome Measures

Inclusion:

* Enrolled in a participating Head Start program
* Age 33 months to 5 years (i.e., meets Head Start age eligibility criteria)

Exclusion:

* Those not meeting inclusion criteria

Secondary Outcome Measures

Inclusion:

* Enrolled in a participating Head Start program
* Age 33 months to 5 years

Exclusion:

* Children not enrolled at a participating Head Start program
* Children less than 29 months or older than 59 months by Sept 1

Answer: C