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

John, Elinor, Cassidy, Dunla M., Playle, Rebecca Anne ORCID: https://orcid.org/0000-0002-2989-1092, Jewell, Karen, Cohen, David, Duncan, Donna Georgina, Newcombe, Robert Gordon ORCID: https://orcid.org/0000-0003-4400-8867, Busse, Monica, Owen-Jones, Eleri, Williams, Nefyn Howard, Longo, Mirella, Avery, Amanda and Simpson, Sharon Anne 2014. 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. BMC Public Health 14 (1) , 439. 10.1186/1471-2458-14-439

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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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Healthcare Sciences Medicine
Subjects:	H Social Sciences > HQ The family. Marriage. Woman H Social Sciences > HV Social pathology. Social and public welfare R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine R Medicine > RG Gynecology and obstetrics
Uncontrolled Keywords:	Study protocol; Pregnancy; Obesity; Complex intervention; Randomised controlled trial; Diet; Physical activity
Publisher:	BioMed Central
ISSN:	1471-2458
Funders:	MRC
Date of First Compliant Deposit:	30 March 2016
Last Modified:	26 Sep 2023 20:11
URI:	https://orca.cardiff.ac.uk/id/eprint/59589

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