Condition category
Nutritional, Metabolic, Endocrine
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Rebecca Lang


Contact details

Gibbet Hill Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

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


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


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



Not Applicable

Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Gibbet Hill Road
United Kingdom

Sponsor information


Department of Health (UK)

Sponsor details

Policy Research Programme
Richmond House
79 Whitehall
United Kingdom

Sponsor type




Funder type


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


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

Basic results (scientific)

Publication list

Results of programme acceptability study in

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