Helping pre-school children to avoid obesity
| ISRCTN | ISRCTN22620137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22620137 |
| Secondary identifying numbers | AH201016 |
- Submission date
- 15/12/2016
- Registration date
- 21/12/2016
- Last edited
- 20/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Childhood 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 Healthy 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
Contact information
Scientific
School of Psychology
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
 ORCID ID |
0000-0001-9851-1236 |
|---|
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An educational intervention to avoid overweight in the pre-school years |
| Study objectives | 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(s) | University of Central Lancashire Ethics Committee, 03/03/20111, ref: PSYAH11 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2010 |
| Completion date | 09/07/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 100 parent-child pairs |
| Total final enrolment | 162 |
| Key inclusion criteria | Parent of a two year old child attending an Early Years Centre in Lancashire, England. |
| Key exclusion criteria | Previous access to the Educational Resource |
| Date of first enrolment | 18/03/2011 |
| Date of final enrolment | 21/07/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Preston
PR1 2HE
United Kingdom
Sponsor information
University/education
Corporation Street
Preston
PR1 2HE
England
United Kingdom
"ROR" |
https://ror.org/010jbqd54 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2019 | 20/11/2019 | Yes | No |
Editorial Notes
20/11/2019: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
26/03/2019: Internal review.
