Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
Condition: Diabetes
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The overall goal of this randomized controlled trial is to test the efficacy of a culturally
      and linguistically modified, individually tailored lifestyle intervention to reduce excess
      gestational weight gain (GWG), increase postpartum weight loss, and improve maternal
      metabolic status among overweight/obese Hispanic women.
    

Detailed description: 
      The overall goal of this randomized controlled trial is to test the efficacy of a culturally
      and linguistically modified, individually tailored lifestyle intervention to reduce excess
      gestational weight gain (GWG), increase postpartum weight loss, and improve maternal
      metabolic status among overweight/obese Hispanic women. Specific aims are to evaluate the
      impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum
      biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin),
      3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4)
      offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and
      5) to evaluate the cost-effectiveness of the intervention per average incremental improvement
      in the outcome variables. Overweight/obese Hispanic women will be recruited in early
      pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150)
      or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will
      utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally
      adapted for Hispanics and shown to be efficacious in our previous controlled trials in this
      ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed
      print-based materials) will be used to deliver the intervention during pregnancy (~12 wks
      gestation to delivery) continuing into postpartum (~6 wks to 6 mos postpartum); follow-up
      will continue for one year postpartum. Targets of the intervention are to achieve Institute
      of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical
      activity through increasing walking and developing a more active lifestyle; and reduction in
      total calories by following a balanced healthy diet in compliance with American Diabetes
      Association guidelines. The intervention draws from Social Cognitive Theory and the
      Transtheoretical Model and includes strategies for partner and/or family support to address
      the specific social, cultural, and economic challenges faced by underserved Hispanic women.
      Measures of compliance will include actigraphs and Hispanic food frequency questionnaires.
      The proposed project builds upon the expertise of the investigative team in conducting
      randomized controlled trials of exercise interventions among Hispanic pregnant women (R01
      DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18
      DK0658850) and can readily be translated into clinical practice in underserved and minority
      populations.
    

Intervention name(s): Lifestyle Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment