Preventing excessive weight gain in pregnant women

ISRCTN	ISRCTN81605162
DOI	https://doi.org/10.1186/ISRCTN81605162
Secondary identifying numbers	11931

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

University of Birmingham
Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
United Kingdom

Email	a.daley@bham.ac.uk

Study information

Study design	Randomised interventional prevention study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	Feasibility and acceptability of the intervention to community midwife.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/06/2012
Completion date	01/10/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	UK Sample Size: 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

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Department of Primary Care & General Practice
Primary Care Clinical Sciences Building
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website	http://www.birmingham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

20/12/2017: Publication reference added.