title: Healthy Moms, a randomized trial to promote and evaluate weight maintenance among obese pregnant women: study design and rationale.
abstract: BACKGROUND
  Obesity and excessive weight gain during pregnancy are associated with adverse pregnancy outcomes. Observational studies suggest that minimal or no gestational weight gain (GWG) may minimize the risk of adverse pregnancy outcomes for obese women.
  
  
  OBJECTIVE
  This report describes the design of Healthy Moms, a randomized trial testing a weekly, group-based, weight management intervention designed to help limit GWG to 3% of weight (measured at the time of randomization) among obese pregnant women (BMI≥30 kg/m(2)). Participants are randomized at 10-20 weeks gestation to either the intervention or a single dietary advice control condition.
  
  
  METHODS
  The study is powered for the primary outcome of total GWG, yielding a target sample size of 160 women. Additional secondary outcomes include weight change between randomization and one-year postpartum and proportion of infants with birth weight>90th percentile for gestational age. Statistical analyses will be based on intention-to-treat.
  
  
  METHODS
  Following randomization, all participants receive a 45-minute dietary consultation. They are encouraged to follow the Dietary Approaches to Stop Hypertension diet without sodium restriction. Intervention group participants receive an individualized calorie intake goal, a second individual counseling session and attend weekly group meetings until they give birth. Research staff assesses all participants at 34-weeks gestation and at 2-weeks and one-year postpartum with their infants.
  
  
  CONCLUSIONS
  The Healthy Moms study is testing weight management techniques that have been used with non-pregnant adults. We aim to help obese women limit GWG to improve their long-term health and the health of their offspring.
authors.affiliation: Center for Health Research, Kaiser Permanente, Northwest, Portland, OR 97227, USA. kimberly.k.vesco@kpchr.org
authors.forename: Kimberly K
authors.initials: KK
authors.lastname: Vesco
authors.forename: Njeri
authors.initials: N
authors.lastname: Karanja
authors.forename: Janet C
authors.initials: JC
authors.lastname: King
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Gillman
authors.forename: Nancy
authors.initials: N
authors.lastname: Perrin
authors.forename: Cindy
authors.initials: C
authors.lastname: McEvoy
authors.forename: Cara
authors.initials: C
authors.lastname: Eckhardt
authors.forename: K Sabina
authors.initials: KS
authors.lastname: Smith
authors.forename: Victor J
authors.initials: VJ
authors.lastname: Stevens
mesh_terms: D000293:Adolescent; D000328:Adult; D001724:Birth Weight; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004035:Diet Therapy / Q000379:methods*; D005081:Exercise Therapy / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D057194:Intention to Treat Analysis; D016015:Logistic Models; D009765:Obesity / Q000628:therapy*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000628:therapy*; D011615:Psychotherapy, Group / Q000379:methods*; D012107:Research Design; D016896:Treatment Outcome; D015430:Weight Gain; D055815:Young Adult