Preventing excessive weight gain in pregnant women
| ISRCTN | ISRCTN81605162 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81605162 |
| Protocol serial number | 11931 |
| Sponsor | University of Birmingham (UK) |
| Funder | National Institute for Health Research |
- Submission date
- 22/03/2012
- Registration date
- 22/03/2012
- Last edited
- 20/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Amanda Daley
Scientific
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional prevention study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Preventing excessive weight gain in healthy and overweight pregnant women |
| Study objectives | 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(s) | ref: 12/WM/0059 |
| Health condition(s) or problem(s) studied | Reproductive Health & Childbirth |
| Intervention | 1. Dietry 2. Education or Self-Management |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Feasibility and acceptability of the intervention to community midwife. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/10/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 90 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/10/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/09/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/12/2017: Publication reference added.
