Lifestyle Intervention to Limit Excessive Weight Gain During Pregnancy in Minority Women
Condition: Pregnancy; Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 4

Summary: 
      The prevalence of overweight and obesity is increasing among pregnant women in the United
      States. More than one-third of women of reproductive age in the US are overweight or obese,
      and two thirds of women gain more weight in pregnancy than is recommended by the Institute of
      Medicine guidelines. Maternal obesity during pregnancy increases the risk of complications to
      both mother and child. Minority women (Blacks and Hispanics) have higher rates of overweight
      and obesity when they become pregnant, experience higher rates of excessive weight gain
      during pregnancy, and experience higher rates of maternal and neonatal complications after
      adjusting for sociodemographic characteristics and comorbidities than Caucasian women.
      Epidemiologic studies indicate that lifestyle modification programs based on diet and
      exercise are promising approaches in controlling weight gain as well as in preventing type 2
      diabetes in populations at risk. We hypothesize that overweight/obese minority women (Blacks
      and Hispanics) assigned to a culturally-grounded lifestyle intervention program based on diet
      and moderate exercise will result in higher compliance with Institute of Medicine guidelines
      for weight gain than women receiving standard care. Such lifestyle modifications should
      reduce risk of maternal and neonatal complications. We propose 1) to determine whether a
      lifestyle intervention program, based on diet and moderate physical activity implemented
      shortly after first recognition of pregnancy, will result in higher compliance with Institute
      of Medicine guidelines for weight gain compared to women receiving standard care; 2) to
      determine the occurrence of carbohydrate intolerance and GDM at 24-28 weeks gestation (after
      the first 10-12 weeks of intervention) and at 6 weeks postpartum between women in the
      lifestyle intervention group and women receiving standard care; and 3) to explore the impact
      of the lifestyle intervention on the development of maternal and fetal complications during
      pregnancy. By limiting excessive weight gain, the lifestyle intervention program may prevent
      the burden of obesity-related complications during pregnancy and reduce risk of subsequently
      developing overt diabetes.
    


Intervention name(s): Lifestyle Intervention group; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks.; Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; weight gain; obesity; pregnancy and weight gain