Protocol Feasibility Study of HENRY
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|ClinicalTrials.gov Identifier: NCT03333733|
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Childhood Obesity||Behavioral: HENRY||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Cluster Randomised Controlled Feasibility Study of HENRY; a Community Based Intervention Aimed at Reducing School Entry Obesity Rates|
|Actual Study Start Date :||July 30, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Children's Centres within local authorities that have been randomised to the experimental arm, HENRY, will receive staff training to deliver the training and be asked to implement at least two programmes per year. Parents enrolled to attend HENRY programmes will then be invited to take part in the research.
HENRY is an 8-week programme delivered in Children's Centres, aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. It is currently delivered in ~ 35 local areas across England and Wales by trained health and community practitioners. Training includes:
Centre Level Training: to equip staff with knowledge and skills to promote and provide healthy nutrition within early years settings and support parents to provide healthy family lifestyles and nutrition for their families. The theoretical underpinning combines proven models of behaviour change including the Family Partnership Model, motivational interviewing and solution-focused support.
Practitioner Level Training: to deliver the 8-week HENRY programme, which aims to build parents' skills, knowledge and confidence to change old habits and provide healthier nutrition for their young children.
Other Name: Health, Exercise, Nutrition for the Really Young
No Intervention: Waiting list control
Children's Centres within local authorities that have been randomised to the control arm will continue with usual practice. Parents attending another programme (Stay and Play) will be invited to take part in the research. At the end of the follow-up period, they will be offered training to deliver HENRY programmes although this will not be compulsory.
- Number of centres recruited [ Time Frame: 12 months from ethical approval ]
- Quality assurance in training achieved [ Time Frame: 12 months from ethical approval ]Pass/fail of training completion recorded by central HENRY team
- Number of parents recruited per centre [ Time Frame: 12 months from completion of training ]
- Intervention fidelity [ Time Frame: 24 months from completion of training ]Adherence to manual identified through observations of intervention sessions
- Contamination risk score [ Time Frame: 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).
- Trial acceptability qualitatively assessed through interviews with participants [ Time Frame: 24 months from centre recruitment ]
- Reference child BMI z-score data [ Time Frame: Measured at follow-up (12 months from parent recruitment) ]Effect size, variance and ICCs to determine sample size
- Reference child BMI z-score [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]Proposed definitive trial outcome - measured height/length and weight
- Primary care giver BMI [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]Proposed definitive trial outcome - measured height and weight
- Family eating activities [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]Proposed definitive trial outcome - 21-item Golan questionnaire
- Parenting self-agency [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]Proposed definitive trial outcome - 5-item Dumka Parenting Self Agency Measure
- Child feeding practices [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]Proposed definitive trial outcome -37-item Baughcum pre-schooler feeding questionnaire
- Dental health [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]Proposed definitive trial outcome -6items related to tooth brushing, dental attendance and whether the child has received general anaesthetic treatment
- Child activity/movement [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]Pedometer worn over 3 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333733
|Medicine and Health||Recruiting|
|Leeds, United Kingdom, ls2 9jt|
|Contact: Maria Bryant, PhD +44 (0)113 343 7632 firstname.lastname@example.org|
|Contact: Lynn Bulmer + (0)113 34 37832 email@example.com|
|Principal Investigator: Maria Bryant, PhD|