Appropriate Gestational Weight Gain in Overweight/Obese Women

NCT02130232 | Completed DMC

• 2 other identifiers: CN-13-16285R01HD073572-02
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Weight Gain

Keywords

Gestational weight gain; Lifestyle; Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Usual Medical Care

Other: Usual Care

Interventions

Lifestyle Intervention BEHAVIORAL

Lifestyle Intervention

Usual Care OTHER

Usual Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Kaiser Permanente Oakland Medical Center

Oakland, California, 94611, United States

Location

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

Location

Related Publications (3)

• 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.

  PMID: 34544560 DERIVED

• 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.

  PMID: 32445736 DERIVED

• 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.

  PMID: 31039753 DERIVED

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assiamira Ferrara, MD PhD

  Kaiser Permanente Division of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 5, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

US (2)