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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
Sponsor:
Collaborator:
NatCen Social Research
Information provided by (Responsible Party):
Maria Bryant, University of Leeds

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.


Condition or disease Intervention/treatment Phase
Obesity Childhood Obesity Behavioral: HENRY Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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

Arm Intervention/treatment
Experimental: HENRY
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.
Behavioral: HENRY

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.



Primary Outcome Measures :
  1. Number of centres recruited [ Time Frame: 12 months from ethical approval ]
  2. Quality assurance in training achieved [ Time Frame: 12 months from ethical approval ]
    Pass/fail of training completion recorded by central HENRY team

  3. Number of parents recruited per centre [ Time Frame: 12 months from completion of training ]
  4. Intervention fidelity [ Time Frame: 24 months from completion of training ]
    Adherence to manual identified through observations of intervention sessions

  5. 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).


Secondary Outcome Measures :
  1. Trial acceptability qualitatively assessed through interviews with participants [ Time Frame: 24 months from centre recruitment ]
  2. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. Family eating activities [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]
    Proposed definitive trial outcome - 21-item Golan questionnaire

  4. 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

  5. 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

  6. 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

  7. Child activity/movement [ Time Frame: Measured at baseline and follow-up (12 months from parent recruitment) ]
    Pedometer worn over 3 days



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Medicine and Health Recruiting
Leeds, United Kingdom, ls2 9jt
Contact: Maria Bryant, PhD    +44 (0)113 343 7632    m.j.bryant@leeds.ac.uk   
Contact: Lynn Bulmer    + (0)113 34 37832    l.bulmer@leeds.ac.uk   
Principal Investigator: Maria Bryant, PhD         
Sponsors and Collaborators
University of Leeds
NatCen Social Research

Study Data/Documents: Childrens Food Trust Report 2012  This link exits the ClinicalTrials.gov site
Reference 4 in citations [there-on other citations are referenced 1 citation later]

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Bryant, Portfolio lead for Diet, Obesity and Lifestyle, University of Leeds
ClinicalTrials.gov Identifier: NCT03333733     History of Changes
Other Study ID Numbers: CDF-2014-07-052
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms