Protocol Feasibility Study of HENRY

NCT03333733 | Completed

• 1 other identifier: CDF-2014-07-052
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Childhood Obesity

Outcome Measures

Primary Outcomes (5)

• Number of centres recruited

  12 months from ethical approval

• Quality assurance in training achieved

  Pass/fail of training completion recorded by central HENRY team

  12 months from ethical approval

• Number of parents recruited per centre

  12 months from completion of training

• Intervention fidelity

  Adherence to manual identified through observations of intervention sessions

  24 months from completion of training

• Contamination risk score

  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).

  24 months from completion of training

Secondary Outcomes (2)

• Trial acceptability qualitatively assessed through interviews with participants

  24 months from centre recruitment

• Reference child BMI z-score data

  Measured at follow-up (12 months from parent recruitment)

Other Outcomes (7)

• Reference child BMI z-score

  Measured at baseline and follow-up (12 months from parent recruitment)

• Primary care giver BMI

  Measured at baseline and follow-up (12 months from parent recruitment)

• Family eating activities

  Measured at baseline and follow-up (12 months from parent recruitment)

Study Arms (2)

HENRY

EXPERIMENTAL

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

Waiting list control

NO INTERVENTION

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.

Interventions

HENRY BEHAVIORAL

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.

Also known as: Health, Exercise, Nutrition for the Really Young

HENRY

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).
• \- 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.

Sponsors & Collaborators

• University of Leeds: lead
• NatCen Social Research: collaborator

Study Sites (1)

Medicine and Health

Leeds, ls2 9jt, United Kingdom

Location

Related Publications (17)

• Singh GK, Kogan MD, van Dyck PC. A multilevel analysis of state and regional disparities in childhood and adolescent obesity in the United States. J Community Health. 2008 Apr;33(2):90-102. doi: 10.1007/s10900-007-9071-7.

  PMID: 18049885 BACKGROUND

• Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. doi: 10.1056/NEJM199709253371301.

  PMID: 9302300 BACKGROUND

• Wang YC, McPherson K, Marsh T, Gortmaker SL, Brown M. Health and economic burden of the projected obesity trends in the USA and the UK. Lancet. 2011 Aug 27;378(9793):815-25. doi: 10.1016/S0140-6736(11)60814-3.

  PMID: 21872750 BACKGROUND

• Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics. 1999 Jun;103(6 Pt 1):1175-82. doi: 10.1542/peds.103.6.1175.

  PMID: 10353925 BACKGROUND

• Oude Luttikhuis H, Baur L, Jansen H, Shrewsbury VA, O'Malley C, Stolk RP, Summerbell CD. Interventions for treating obesity in children. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001872. doi: 10.1002/14651858.CD001872.pub2.

  PMID: 19160202 BACKGROUND

• Waters E, de Silva-Sanigorski A, Hall BJ, Brown T, Campbell KJ, Gao Y, Armstrong R, Prosser L, Summerbell CD. Interventions for preventing obesity in children. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD001871. doi: 10.1002/14651858.CD001871.pub3.

  PMID: 22161367 BACKGROUND

• Morandi A, Meyre D, Lobbens S, Kleinman K, Kaakinen M, Rifas-Shiman SL, Vatin V, Gaget S, Pouta A, Hartikainen AL, Laitinen J, Ruokonen A, Das S, Khan AA, Elliott P, Maffeis C, Gillman MW, Jarvelin MR, Froguel P. Estimation of newborn risk for child or adolescent obesity: lessons from longitudinal birth cohorts. PLoS One. 2012;7(11):e49919. doi: 10.1371/journal.pone.0049919. Epub 2012 Nov 28.

  PMID: 23209618 BACKGROUND

• Leblanc ES, O'Connor E, Whitlock EP, Patnode CD, Kapka T. Effectiveness of primary care-relevant treatments for obesity in adults: a systematic evidence review for the U.S. Preventive Services Task Force. Ann Intern Med. 2011 Oct 4;155(7):434-47. doi: 10.7326/0003-4819-155-7-201110040-00006.

  PMID: 21969342 BACKGROUND

• Loveman E, Frampton GK, Shepherd J, Picot J, Cooper K, Bryant J, Welch K, Clegg A. The clinical effectiveness and cost-effectiveness of long-term weight management schemes for adults: a systematic review. Health Technol Assess. 2011 Jan;15(2):1-182. doi: 10.3310/hta15020.

  PMID: 21247515 BACKGROUND

• Summerbell CD, Ashton V, Campbell KJ, Edmunds L, Kelly S, Waters E. Interventions for treating obesity in children. Cochrane Database Syst Rev. 2003;(3):CD001872. doi: 10.1002/14651858.CD001872.

  PMID: 12917914 BACKGROUND

• Blake-Lamb TL, Locks LM, Perkins ME, Woo Baidal JA, Cheng ER, Taveras EM. Interventions for Childhood Obesity in the First 1,000 Days A Systematic Review. Am J Prev Med. 2016 Jun;50(6):780-789. doi: 10.1016/j.amepre.2015.11.010. Epub 2016 Feb 22.

  PMID: 26916260 BACKGROUND

• Redsell SA, Edmonds B, Swift JA, Siriwardena AN, Weng S, Nathan D, Glazebrook C. Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood. Matern Child Nutr. 2016 Jan;12(1):24-38. doi: 10.1111/mcn.12184. Epub 2015 Apr 20.

  PMID: 25894857 BACKGROUND

• Hillier F, Pedley C, Summerbell C. Evidence base for primary prevention of obesity in children and adolescents. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Mar;54(3):259-64. doi: 10.1007/s00103-010-1227-4.

  PMID: 21347757 BACKGROUND

• Willis TA, George J, Hunt C, Roberts KP, Evans CE, Brown RE, Rudolf MC. Combating child obesity: impact of HENRY on parenting and family lifestyle. Pediatr Obes. 2014 Oct;9(5):339-50. doi: 10.1111/j.2047-6310.2013.00183.x. Epub 2013 Jul 2.

  PMID: 23818487 BACKGROUND

• Stamp E, Schofield H, Roberts VL, Burton W, Collinson M, Stevens J, Farrin A, Rutter H, Bryant M. Contamination within trials of community-based public health interventions: lessons from the HENRY feasibility study. Pilot Feasibility Stud. 2021 Mar 26;7(1):88. doi: 10.1186/s40814-021-00805-3.

  PMID: 33771233 DERIVED

• Bryant M, Collinson M, Burton W, Stamp E, Schofield H, Copsey B, Hartley S, Webb E, Farrin AJ. Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children. Pilot Feasibility Stud. 2021 Feb 26;7(1):59. doi: 10.1186/s40814-021-00798-z.

  PMID: 33632330 DERIVED

• Bryant M, Burton W, Collinson M, Hartley S, Tubeuf S, Roberts K, Sondaal AEC, Farrin AJ. Cluster randomised controlled feasibility study of HENRY: a community-based intervention aimed at reducing obesity rates in preschool children. Pilot Feasibility Stud. 2018 Jun 21;4:118. doi: 10.1186/s40814-018-0309-1. eCollection 2018.

  PMID: 29977593 DERIVED

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Interventions

Health; Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Portfolio lead for Diet, Obesity and Lifestyle

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: November 7, 2017
• Study Start: July 30, 2017
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)