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Appropriate Gestational Weight Gain in Overweight/Obese Women

NCT02130232 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 398

Last updated 2020-04-07

No results posted yet for this study

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

Interventions

BEHAVIORAL

Lifestyle Intervention

OTHER

Usual Care

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Assiamira Ferrara, MD PhD · Kaiser Permanente Division of Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2019-02-28
Completion
2020-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02130232 on ClinicalTrials.gov