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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN25260464 Date of registration: 16th April 2010.
authors.forename: Elinor
authors.initials: E
authors.lastname: John
authors.forename: Dunla M
authors.initials: DM
authors.lastname: Cassidy
authors.forename: Rebecca
authors.initials: R
authors.lastname: Playle
authors.forename: Karen
authors.initials: K
authors.lastname: Jewell
authors.forename: David
authors.initials: D
authors.lastname: Cohen
authors.forename: Donna
authors.initials: D
authors.lastname: Duncan
authors.forename: Robert G
authors.initials: RG
authors.lastname: Newcombe
authors.forename: Monica
authors.initials: M
authors.lastname: Busse
authors.forename: Eleri
authors.initials: E
authors.lastname: Owen-Jones
authors.forename: Nefyn
authors.initials: N
authors.lastname: Williams
authors.forename: Mirella
authors.initials: M
authors.lastname: Longo
authors.forename: Amanda
authors.initials: A
authors.lastname: Avery
authors.affiliation: South East Wales Trials Unit, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff CF14 4YS, UK. simpsonsa@cf.ac.uk.
authors.forename: Sharon A
authors.initials: SA
authors.lastname: Simpson
mesh_terms: D000293:Adolescent; D000328:Adult; D015992:Body Mass Index; D016000:Cluster Analysis; D004032:Diet / Q000379:methods*; D015444:Exercise; D005260:Female; D015438:Health Behavior; D006801:Humans; D008019:Life Style; D008880:Midwifery; D009765:Obesity / Q000517:prevention & control* / Q000628:therapy; D011181:Postnatal Care / Q000379:methods; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control* / Q000628:therapy; D015397:Program Evaluation / Q000379:methods*; D011788:Quality of Life; D016896:Treatment Outcome; D006113:United Kingdom; D061217:Weight Reduction Programs / Q000379:methods; D055815:Young Adult