Appropriate Gestational Weight Gain in Overweight/Obese Women
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Gestational Weight Gain
- Sponsor
- Kaiser Permanente
- Enrollment
- 398
- Locations
- 2
- Primary Endpoint
- Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The goal of this trial is to investigate the efficacy of a lifestyle intervention of healthy diet and physical activity for helping overweight/obese pregnant women to achieve appropriate gestational weight gain (GWG) for their prepregnancy body mass index (BMI). The goal of the intervention is to help women achieve the lower bound of the GWG range recommended by the Institutes of Medicine (IOM) for a given prepregnancy BMI category (i.e., 11 lbs for obese women and 15 lbs for overweight women). The lifestyle intervention will be delivered via 2 in-person counseling sessions and 11 telephone contacts with study dieticians trained in motivational interviewing techniques. The lifestyle intervention will be compared to usual medical care. Outcomes will be assessed by trained study personnel at approximately 10 weeks and 32 weeks gestation, within several days of delivery and at 6 months and 12 months postpartum.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregravid BMI 25 to \<40 (as determined from a measured pregravid weight in electronic medical record)
Exclusion Criteria
- •Cardiovascular disease
- •Gastrointestinal disease
- •Bariatric surgery
- •Lung disease
- •Thyroid disease
- •Eating disorder
- •Bed rest or Gestational Diabetes in the current pregnancy
- •Planning to get pregnant again or move within 1 year of delivery
- •Substance abuse
- •Serious mental health disorders
Outcomes
Primary Outcomes
Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week
Time Frame: from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Rate of gestational weight gain per week
Time Frame: From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
Secondary Outcomes
- Diet - proportion of calories from fat(Change in proportion of calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation)
- Physical Activity(Change in physical activity between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Rate of gestational weight gain between study clinical assessments(Rate of gestational weight gain between approximately 10 weeks and 32 weeks gestation (kilograms per week))
- Metabolic marker - leptin(Change in leptin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Metabolic marker - adiponectin(Change in adiponectin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Total gestational weight gain(from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks)
- Proportion of women exceeding the Institute of Medicine's recommendation for total gestational weight gain per week(From pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks)
- Diet - total calories from fat(Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation)
- Metabolic marker - glycemia(Change in glucose between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Metabolic marker - lipids(Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))
- Metabolic marker - insulinemia(Change in insulin between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately))