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
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
-
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.