Appropriate Gestational Weight Gain in Overweight/Obese Women
- Conditions
- Gestational Weight Gain
- Interventions
- Behavioral: Lifestyle InterventionOther: Usual Care
- Registration Number
- NCT02130232
- Lead Sponsor
- Kaiser Permanente
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 398
- Pregnant
- Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record)
- Diabetes
- Cardiovascular disease
- Gastrointestinal disease
- Bariatric surgery
- Lung disease
- Thyroid disease
- Eating disorder
- Cancer
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle Intervention Lifestyle Intervention 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 pregnancy lifestyle intervention will be delivered by trained study dieticians via individual counseling sessions: 2 in-person and 11 telephone sessions delivered on a weekly basis, followed by telephone sessions delivered every other week through the end of pregnancy. Usual Care Usual Care Usual Medical Care
- Primary Outcome Measures
Name Time Method Proportion of women exceeding the Institute of Medicine's recommendation for rate of gestational weight gain per week from pre-pregnancy weight up to 21 weeks to 42 weeks of pregnancy Rate of gestational weight gain per week From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
- Secondary Outcome Measures
Name Time Method Diet - total calories from fat Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation 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 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)
Trial Locations
- Locations (2)
Kaiser Permanente Oakland Medical Center
🇺🇸Oakland, California, United States
Kaiser Permanente Santa Clara Medical Center
🇺🇸Santa Clara, California, United States