Condition category
Nutritional, Metabolic, Endocrine
Date applied
15/12/2016
Date assigned
21/12/2016
Last edited
20/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
hildhood obesity is a growing concern worldwide, which can lead to serious health problems such as diabetes, heart disease and even cancer. Many children aged 2 to 4 years in England attend Early Years Centres and this provides an opportunity to see if a healthy lifestyle programme can prevent obesity before children enter the formal school system at age 4 years. The aim of this study is to test the effectiveness of a healthy lifestyle programme in preventing obesity in children aged two-four years old.

Who can participate?
Parents and their two-year old children who attend participating Early Years Centres.

What does the study involve?
Participating Early years centres are randomly allocated to one of two groups. In the first group, staff are trained to deliver an educational resource 'Be Active, Eat Healthy'. In these centres, the ealthy Heroes educational package of activities (which encourages healthy eating and physical activity) is delivered to two-year old children and their parents. In the second group, staff do not receive any training and work with attending families as normal. Staff in all centres are interviewed before and after the 'training' to assess their policies and health promotion activities. All children in the study are weighed at the start of the study and at 6 months, 12 months and 2 years after the start. Parents complete a number of questionnaires about their child's eating behaviour, style of feeding their child, and about their own mental and physical wellbeing. These questionnaires are completed at the start and at two years after the start of the study.

What are the possible benefits and risks of participation?
Parents and children will learn about the benefits of healthy eating and being active. Monitoring weight, eating behaviour and physical activity may help children achieve and maintain a health weight. There are no risks involved in this study.

Where is the study run from?
The study is run from University of Central Lancashire and takes place in 10 Early Years Centres in Lancashire (UK)

When is the study starting and how long is it expected to run for?
September 2010 to July 2016

Who is the main contact?
Professor Janice Abbott
jabbott@uclan.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Janice Abbott

ORCID ID

http://orcid.org/0000-0001-9851-1236

Contact details

School of Psychology
University of Central Lancashire
Preston
PR1 2HE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

AH201016

Study information

Scientific title

An educational intervention to avoid overweight in the pre-school years

Acronym

Study hypothesis

Children in the intervention group will have a different change in BMI z-score between 2 and 4 years of age compared to children in a control group not receiving the intervention.

Ethics approval

University of Central Lancashire Ethics Committee, 03/03/20111, ref: PSYAH11

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

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

Condition

Childhood obesity

Intervention

Early Years Centres will be selected and matched in terms of their locality and the social and economic status of the children attending the centres. The matched centres will be randomly allocated to be intervention or control centres.

Interventions group: Staff receive training at Early Years Centres in the educational resource 'Be Active, Eat Healthy'. This will be provided by Lancashire County Council’s Children and Young People’s Team, NHS Public Health personnel and NHS Early Years Health Practitioners. Policies, provision and health promotion on healthy eating and physical activity will be assessed in the Early Years Centres at baseline and at 12 month follow-up. The 'Healthy Heroes Activity Pack' for participating parents and children is then delivered by trained Early Years staff (www.lhsp.org.uk/healthyheroes).

Control group: Staff do not receive any training and work with attending families as normal.

For all participants, interviews will be arranged for each family for assessments at baseline, 6 months, 12 months and 2 years post baseline. At each assessment, the parent and child will be weighed, and have their height and waist circumference measured. A parent-report battery of valid and reliable questionnaires will be administered at baseline and at 2 years.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Child BMI z-score is measured using height and weight measurements taken at baseline, 6 months, 1 and 2 years.

Secondary outcome measures

1. Child eating behaviour is assessed using the Child Eating Behaviour Questionnaire at baseline and 2 years
2. Parent style of feeding their child is assessed using the Parental Feeding Style Questionnaire at baseline and 2 years
3. Mental wellbeing is assessed using the Warwick and Edinburgh Mental Wellbeing Scale at baseline and 2 years

Overall trial start date

01/09/2010

Overall trial end date

09/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Parent of a two year old child attending an Early Years Centre in Lancashire, England.

Participant type

Healthy volunteer

Age group

Mixed

Gender

Both

Target number of participants

100 parent-child pairs

Participant exclusion criteria

Previous access to the Educational Resource

Recruitment start date

18/03/2011

Recruitment end date

21/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Central Lancashire
Fylde Road
Preston
PR1 2HE
United Kingdom

Sponsor information

Organisation

University of Central Lancashire

Sponsor details

Corporation Street
Preston
PR1 2HE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Lancashire County Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal in 2017.

IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes