Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/02/2018
Date assigned
05/03/2018
Last edited
07/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is increasing concern about rates of childhood obesity in the UK. The HENRY Programme helps parents to adopt healthier family lifestyles and habits such as family mealtimes and building activities into weekly routines. It is designed for parents or carers of pre-school children who are obese or at risk of obesity. The aim of this study is to find out whether the HENRY Programme is effective for families.

Who can participate?
Parents/carers with children aged under 5 years, HENRY-trained practitioners/Family Support Workers, HENRY operational and project leads, and Local Authority commissioners

What does the study involve?
Parents/carers attend the HENRY Programme which consists of eight sessions of 2.5 hours duration. Parents are asked to evaluate their own progress in the following areas: parenting skills, emotional well-being, healthy lifestyle, healthy eating and increased activity. Interviews are also conducted with parents after the Programme has finished to find out whether they have been able to maintain the changes they have made. HENRY group facilitators, HENRY managers and local authority commissioners are interviewed regarding the implementation of the Programme.

What are the possible benefits and risks of participating?
Previous research suggests that HENRY helps people to make positive changes for themselves and their families. The interviews allow participants to give their views on the HENRY Programme. There are no anticipated risks.

Where is the study run from?
1. University of Bedfordshire (UK)
2. Flying Start Luton (UK)

When is the study starting and how long is it expected to run for?
February 2016 to November 2018

Who is funding the study?
1. University of Bedfordshire (UK)
2. Flying Start Luton (UK)

Who is the main contact?
Dr Rosemary Davidson
rosemary.davidson@beds.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rosemary Davidson

ORCID ID

http://orcid.org/0000-0002-0010-4809

Contact details

Institute for Health Research
University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom
+44 (0)7966676974
rosemary.davidson@beds.ac.uk

Type

Scientific

Additional contact

Prof Gurch Randhawa

ORCID ID

http://orcid.org/0000-0002-2289-5859

Contact details

Institute for Health Research
University of Bedfordshire
Putteridge Bury Campus
Hitchin Road
Luton
LU2 8LE
United Kingdom
-
gurch.randhawa@beds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FS_HENRY

Study information

Scientific title

Reducing levels of obesity in pre-school children: A Process and Outcome Evaluation of the HENRY Programme, Luton, UK

Acronym

HENRY

Study hypothesis

The HENRY Programme uses behaviour change and self management approaches to support parents to adopt healthier family lifestyles thus reducing levels of childhood obesity.

Ethics approval

University Research Ethics Committee, University of Bedfordshire, 10/04/2017, ref: UREC103

Study design

Process and outcome evaluation of a single-centre targeted intervention versus national database of matched behavioural outcomes

Primary study design

Interventional

Secondary study design

Process study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Childhood obesity

Intervention

The HENRY Programme trains Early Years Practitioners (suitable for Health Visitors, Midwives, Children’s Centre workers, Nutritionists, Dieticians and Childminders) usually based in Children’s Centres to facilitate groups with families and carers of 0 to 5 year olds. The eight week programme (2.5 hours per week) builds upon mutual support and praise, with families and facilitators working together to focus on factors known to be associated with later obesity. The approach is based on behaviour change and self management techniques.

The study design is a process and outcome evaluation using a mixed method approach. The process evaluation aims to understand how and why the intervention was adopted, drivers and barriers to implementation and the role of context. With respect to HENRY this will involve semi-structured interviews with families, staff and stakeholders at agreed time points throughout the delivery of the HENRY Programme, and observations of staff training and HENRY sessions and settings.

The outcome evaluation will measure the progress of families who attend the HENRY Programme. The study will monitor specific HENRY outcomes: parenting skills, emotional well-being, healthy lifestyle, healthy eating, and increased physical activity.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Self-reported measures pre and post HENRY (8 weeks) and 12 weeks post Programme:
1. Parenting skills (self rated confidence; cooperation and setting limits)
2. Emotional well-being (stress levels)
3. Healthy lifestyle (types of activity, screen time)
4. Healthy eating (eating patterns, cooking)
5. Increased activity (duration)
6. Parent attendance, documented over the 8 week duration of the course and reasons for absence (family issues, illness, change of job, uncomfortable with course or faciliator etc.) coded where possible

Secondary outcome measures

1. What went well, less well, what they would do differently, group dynamics, any parents appearing uncomfortable, reviewed by Group Facilitators each session
2. Overall impressions of HENRY including changes observed in parents and any challenges identified, reviewed by facilitators at the end of the Programme
3. Parents' level of enjoyment rated on a likert scale and further comments, collected using an anonymous appraisal at the end of the Programme

Overall trial start date

01/02/2016

Overall trial end date

01/11/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parents/carers with children under 5 years
2. HENRY trained practitioners/Family Support Workers
3. HENRY operational and project leads
4. Local Authority commissioners

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Persons with no experience of HENRY
2. Persons with no experience of working in the early years sector

Recruitment start date

01/05/2017

Recruitment end date

01/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute for Health Research
University of Bedfordshire University Square
Luton
LU1 3JU
United Kingdom

Trial participating centre

Flying Start Luton
The TOKKO Building 7 Gordon Street
Luton
LU1 2PQ
United Kingdom

Sponsor information

Organisation

Institute for Health Research

Sponsor details

University of Bedfordshire
University Square
Luton
LU1 3JU
United Kingdom

Sponsor type

University/education

Website

https://www.beds.ac.uk/research-ref/ihr/contactus

Organisation

Flying Start Luton

Sponsor details

The TOKKO Building
7 Gordon Street
Luton
LU1 2QP
United Kingdom

Sponsor type

Government

Website

https://www.flyingstartluton.com

Funders

Funder type

University/education

Funder name

University of Bedfordshire

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Flying Start Luton

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Study protocol is available on request. One outcome and one process evaluation article are planned. The outcome article will report on the pre- and post behavioural measures collected from participants. The process evaluation article will report on implementation and progress of the HENRY Programme.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rosemary Davidson (rosemary.davidson@beds.ac.uk). Process and outcome data will be available from November 2018 for three years post evaluation. Any data requests will be subject to HENRY approval for post hoc analyses. All data is anonymised. Consent has been obtained from participants for their anonymised data to be used.

Intention to publish date

01/06/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2018: Prof Gurch Randhawa has been added as a scientific contact