Condition category
Pregnancy and Childbirth
Date applied
22/03/2012
Date assigned
22/03/2012
Last edited
13/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.birmingham.ac.uk/

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

Publication citations

Additional files

Editorial Notes