Appropriate Gestational Weight Gain in Overweight/Obese Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Gestational Weight Gain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

Usual Care

Usual Medical Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Interventions

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Lifestyle Intervention

Intervention Type BEHAVIORAL

Usual Care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No