Appropriate Gestational Weight Gain in Overweight/Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Gestational Weight Gain
• Intervention / Treatment: Other: Usual Care; Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94611
      • Kaiser Permanente Oakland Medical Center
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Santa Clara Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Lifestyle Intervention
Active Comparator: Usual Care; Usual Medical Care	Other: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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)
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)
Metabolic marker - glycemia	Change in glucose 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)
Metabolic marker - lipids	Change in lipids between study clinical assessments in pregnancy (i.e., between 10 weeks and 32 weeks gestation, approximately)
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)

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Assiamira Ferrara, MD PhD, Kaiser Permanente Division of Research

Publications and helpful links

General Publications

• Jake-Schoffman DE, Brown SD, Baiocchi M, Bibeau JL, Daubenmier J, Ferrara A, Galarce MN, Hartogensis W, Hecht FM, Hedderson MM, Moran PJ, Pagoto SL, Tsai AL, Waring ME, Kiernan M. Methods-Motivational Interviewing Approach for Enhanced Retention and Attendance. Am J Prev Med. 2021 Oct;61(4):606-617. doi: 10.1016/j.amepre.2021.04.005.
• Ferrara A, Hedderson MM, Brown SD, Ehrlich SF, Tsai AL, Feng J, Galarce M, Marcovina S, Catalano P, Quesenberry CP. A telehealth lifestyle intervention to reduce excess gestational weight gain in pregnant women with overweight or obesity (GLOW): a randomised, parallel-group, controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):490-500. doi: 10.1016/S2213-8587(20)30107-8.
• Brown SD, Hedderson MM, Ehrlich SF, Galarce MN, Tsai AL, Quesenberry CP, Ferrara A. Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity. BMC Pregnancy Childbirth. 2019 Apr 30;19(1):145. doi: 10.1186/s12884-019-2293-8.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Actual): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Intervention; Gestational weight gain; Lifestyle
• Additional Relevant MeSH Terms: Body Weight Changes; Overweight; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: CN-13-1628; 5R01HD073572-02 (U.S. NIH Grant/Contract)