Contact information
Type
Scientific
Primary contact
Dr Amanda Daley
ORCID ID
Contact details
University of Birmingham
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
a.daley@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11931
Study information
Scientific title
Preventing excessive weight gain in healthy and overweight pregnant women
Acronym
Study hypothesis
Gaining too much weight during pregnancy can have many negative effects, including gestational diabetes and complications when the baby is delivered. Many pregnant women gain more weight than they should during pregnancy. Studies have shown that many women reduce their physical activity and consume a more liberal diet during and after pregnancy.
Ethics approval
ref: 12/WM/0059
Study design
Randomised interventional prevention study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Reproductive Health & Childbirth
Intervention
1. Dietry
2. Education or Self-Management
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Feasibility and acceptability of the intervention to community midwife.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2012
Overall trial end date
01/10/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Low risk pregnant women receiving community midwife led/shared care
2. Aged at least 18
3. Within healthy or over weight BMI ranges (1830 kg/m2) at the 5/6 week gestation appoinment and scan/booking visit (12 - 14 weeks gestation
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
UK Sample Size: 90
Participant exclusion criteria
1. Obese women (BMI =30 (kg/m2) - as the focus is primary prevention and because obese women are deemed high risk and typically receive consultant led care.
2. Other women deemed high risk by the CMW at the booking appointment will not be invited to take part (e.g. more than one foetus, history of complications, preexisting chronic illness etc).
3. If a woman is deemed high risk at any time after the booking visit, the CMW will determine whether it is appropriate for her to continue in the study, but where possible we will try to retain them.
Recruitment start date
01/06/2012
Recruitment end date
01/10/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26401345