Maternal-Offspring Metabolics:Family Intervention Trial
Condition: Pregnancy; Weight Gain
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The prevalence of maternal overweight and obesity has nearly doubled in the United States
      since 1976. In 2004-2005, 42% of pregnant women had body mass index (BMI) above 25 versus 23%
      in 1993. Most American women are overweight/ obese (OW/OB) at conception, especially within
      certain racial, ethnic, and lower socioeconomic groups leading to increased adverse maternal
      and birth outcomes. This study will recruit, randomize and test in 300 ethnically diverse
      OW/OB pregnant women a behavioral intervention aimed at controlling gestational weight gain
      (GWG) through recommended diet, activity and lifestyle changes that are to be maintained
      postpartum. Outcomes include anthropometric (height, weight, percent body fat) metabolic
      (blood pressure, fasting glucose, insulin, HbA1c, lipids and C-reactive protein) and
      behavioral measures (diet. physical activity, sleep and stress). In addition, babies will be
      measured for length, weight and percent body fat. The goal is to limit excessive gestational
      weight gain through improved maternal lifestyle that can be maintained and modelled for the
      family post partum and beyond.
    

Detailed description: 
      A Randomized Control Trial is planned among ethnically diverse OW/OB pregnant women ages
      18-45 years to be randomly assigned to the MOMFIT Active Intervention Group (AIG) or the
      Educational Control Group (ECG) plus standard obstetrical care. The Dietary Approaches to
      Stop Hypertension (DASH) diet, along with moderate physical activity and group intervention
      as utilized in the Diabetes Prevention Program (DPP), will be adapted for pregnant and
      postpartum women through individual visits to tailor calorie/nutrient/activity goals, plus
      group coaching sessions and electronic self-monitoring behavior. Evidence based motivational
      interviewing and state of the art self-monitoring tools involving the LoseIt app will be
      adapted for pregnant/postpartum women via smartphone or Internet access, along with tailored
      feedback and encouragement from the Lifestyle Coach. Prevention of excessive GWG and
      achievement of the Institute Of Medicine (IOM) weight gain goals will be compared between
      groups, whether ongoing adherence to the lifestyle interventions can be sustained through
      postpartum intervention. Approximately one third of the participants are expected to be
      minorities and/or from low income backgrounds. The primary outcome is gestational weight gain
      from baseline (self-reported prepregnancy weight) to near delivery (36 weeks) compared with
      IOM goals in both groups and postpartum weight retention between 6 weeks and 12 months
      postpartum. Additional outcome variables include changes in maternal Body Mass Index (BMI)
      and adiposity postpartum, blood pressure, blood glucose, insulin, Hemoglobin A1c (HbA1c),
      C-reactive Protein (CRP), and lipids, diet quality, and physical activity levels, offspring
      adiposity and anthropometrics, and glucose and C-peptide in cord blood
    

Intervention name(s): Lifestyle Intervention Group; Usual Care Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer; Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pregnancy; Weight gain; Obesity; Pregnancy and weight gain