Appropriate Gestational Weight Gain in Overweight/Obese Women

Not Applicable

Completed

• Conditions: Gestational Weight Gain

• 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

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-05
• Primary Completion: 2019-02
• Study Completion: 2020-02
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 398

Inclusion Criteria

• Pregnant
• Pregravid BMI 25 to <40 (as determined from a measured pregravid weight in electronic medical record)

Exclusion Criteria

• 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

Primary Outcome Measures

Name	Time	Method
Rate of gestational weight gain per week	From pre-pregnancy weight to last pregnancy weight up to 21 weeks to 42 weeks of pregnancy
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

Secondary Outcome Measures

Name	Time	Method
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)
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)
Diet - total calories from fat	Change in total calories from fat between study clinical assessments in pregnancy between 10 weeks and 32 weeks gestation
Total gestational weight gain	from pre-pregnancy weight to last pregnancy weight up to 24 weeks to 42 weeks

Trial Locations

Locations (2)

Kaiser Permanente Oakland Medical Center; 🇺🇸 Oakland, California, United States

Kaiser Permanente Santa Clara Medical Center; 🇺🇸 Santa Clara, California, United States