Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/05/2010
Date assigned
19/05/2010
Last edited
23/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebecca Lang

ORCID ID

Contact details

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4880

Study information

Scientific title

Empowering Parents to Prevent Obesity at Weaning - Exploratory Research: Royal College of Paediatrics and Child Health (RCPCH) pilot and feasibility study

Acronym

EMPOWER

Study hypothesis

This is a Department of Health funded study to test the feasibility of a programme designed to prevent obesity at weaning (EMPOWER). The study is being conducted by researchers at the Universities of Warwick and Leeds.

The aims are as follows:
1. To pilot an intervention developed by the Royal College of Paediatrics and Child Health and the Child Health Obesity Group
2. Ascertain the feasibility and acceptability of the intervention and prepare for a randomised controlled trial (RCT) to determine clinical effectiveness

Ethics approval

South Birmingham Ethics Committee approved on the 1st June 2007 (ref: 07/Q2707/114)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for England; Subtopic: Not Assigned, Generic Health Relevance (all Subtopics); Disease: All Diseases, Public Health Research

Intervention

Pilot study (9 months, n = 16):
The pilot will take place at two locations: Leeds and Warwick and will be delivered by two specially trained health visitors. The aim will be for each health visitor to work with 8 families at each site. The outcome measures provisionally selected for use in the feasibility trial will be administered at baseline and at 6 months, by the health visitor. In-depth interviews will be conducted with the health visitors, service providers and participating families twice during the pilot phase and will explore user and provider satisfaction; perceptions about the acceptability of the intervention, its content, its usefulness and the quality of the resources; and the outcome measures. This data will be used to modify and enhance the programme. Process data will also be collected regarding recruitment, number of sessions received by each participant etc. The results of this analysis will contribute to an understanding of the acceptability and feasibility of the intervention, and will also help shape the recruitment strategy for the feasibility trial.

Exploratory trial (24 months, n = 64):
This stage of the study will involve and assessing the feasibility of conducting a randomised controlled trial. Of the intervention by delivering the intervention to a group of 32 infants and 32 control infants (at the above two locations) The following data will be collected:
1. Process data - qualitative and quantitative data from participating families concerning the intervention such as number of sessions received by each participant, drop-out, satisfaction with the intervention etc
2. Quantitative data
3. Qualitative data - in-depth interviews with families and service providers
4. Cost data

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Recruitment rate and acceptability of randomisation
2. Acceptability of the trial methodology

Data collection periods are at baseline (when the infant is 4 - 6 weeks old), when the infant is 9 months old, and again at 18 months of age. The primary outcomes will be assessed quantitatively at recruitment as well as qualitatively at the end of the trial.

Secondary outcome measures

Infant outcomes:
1. Infant weight gain on scales
2. Infant diet: diet and eating behaviour questionnaire
3. Eating pattern

Parental outcomes:
1. Maternal weight and body mass index (BMI)
2. Maternal and family diet: food frequency questionnaire

Data collection periods are at baseline (when the infant is 4 - 6 weeks old), when the infant is 9 months old, and again at 18 months of age. The secondary outcomes will be analysed against baseline at the two timepoints mentioned above.

Overall trial start date

01/09/2007

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women with a pre-pregnancy body mass index (BMI) of greater than or equal to 35 kg/m^2
2. Aged 16 years or over
3. Able to understand and communicate in English
4. Live within the Primary Care Trusts (PCT) area recruiting for the study (namely Leeds PCT and Heart of Birmingham PCT)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned sample size: 64

Participant exclusion criteria

1. Obesity has a medical cause
2. Develop pre-eclampsia or gestational diabetes during their pregnancy
3. Baby is born with any birth defects
4. Infant is on the child protection register
5. The woman has learning difficulties and is unable to fully understand the requirements of the study, or the woman's comprehension of English is insufficient to enable her to fully understand the study requirements

Recruitment start date

01/09/2007

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Policy Research Programme
Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

Department of Health (UK) - National Service Framework (NSF) for Children, Young People and Maternity Services

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results of programme acceptability study in http://www.ncbi.nlm.nih.gov/pubmed/20645998

Publication citations

  1. Results of programme acceptability study

    Barlow J, Whitlock S, Hanson S, Davis H, Hunt C, Kirkpatrick S, Rudolf M, Preventing obesity at weaning: parental views about the EMPOWER programme., Child Care Health Dev, 2010, 36, 6, 843-849, doi: 10.1111/j.1365-2214.2010.01107.x.

Additional files

Editorial Notes