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BMC Public Health
Published in: BMC Public Health 1/2014

Open Access 01-12-2014 | Study protocol

Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy

Authors: Elinor John, Dunla M Cassidy, Rebecca Playle, Karen Jewell, David Cohen, Donna Duncan, Robert G Newcombe, Monica Busse, Eleri Owen-Jones, Nefyn Williams, Mirella Longo, Amanda Avery, Sharon A Simpson

Published in: BMC Public Health | Issue 1/2014

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Abstract

Background

Approximately 1 in 5 pregnant women in the United Kingdom are obese. In addition to being associated generally with poor health, obesity is known to be a contributing factor to pregnancy and birth complications and the retention of gestational weight can lead to long term obesity.
This paper describes the protocol for a cluster randomised trial to evaluate whether a weight management intervention for obese pregnant women is effective in reducing women’s Body Mass Index at 12 months following birth.

Methods/design

The study is a cluster randomised controlled trial involving 20 maternity units across England and Wales. The units will be randomised, 10 to the intervention group and 10 to the control group. 570 pregnant women aged 18 years or over, with a Body Mass Index of +/=30 (kg/m2) and between 12 and 20 weeks gestation will be recruited. Women allocated to the control group will receive usual care and two leaflets giving advice on diet and physical activity. In addition to their usual care and the leaflets, women allocated to the intervention group will be offered to attend a weekly 1.5 hour weight management group, which combines expertise from Slimming World with clinical advice and supervision from National Health Service midwives, until 6 weeks postpartum.
Participants will be followed up at 36 weeks gestation and at 6 weeks, 6 months and 12 months postpartum. Body Mass Index at 12 months postpartum is the primary outcome. Secondary outcomes include pregnancy weight gain, quality of life, mental health, waist-hip ratio, child weight centile, admission to neonatal unit, diet, physical activity levels, pregnancy and birth complications, social support, self-regulation and self-efficacy. A cost effectiveness analysis and process evaluation will also be conducted.

Discussion

This study will evaluate the effectiveness of a theory-based intervention developed for obese pregnant women. If successful the intervention will equip women with the necessary knowledge and skills to enable them to make healthier choices for themselves and their unborn child.

Trial registration

Current Controlled Trials: ISRCTN25260464
Date of registration: 16th April 2010.
Appendix
Available only for authorised users
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Metadata
Title
Healthy eating and lifestyle in pregnancy (HELP): a protocol for a cluster randomised trial to evaluate the effectiveness of a weight management intervention in pregnancy
Authors
Elinor John
Dunla M Cassidy
Rebecca Playle
Karen Jewell
David Cohen
Donna Duncan
Robert G Newcombe
Monica Busse
Eleri Owen-Jones
Nefyn Williams
Mirella Longo
Amanda Avery
Sharon A Simpson
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2014
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/1471-2458-14-439

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