Appropriate Gestational Weight Gain in Overweight/Obese Women

Kaiser Permanente

Status: Completed

Conditions: Gestational Weight Gain

Treatments: Behavioral: Lifestyle Intervention; Other: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02130232

5R01HD073572-02 (U.S. NIH Grant/Contract)

CN-13-1628

Details and patient eligibility

About

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.

Enrollment: 398 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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398 participants in 2 patient groups

Lifestyle Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Lifestyle Intervention

Usual Care

Active Comparator group

Description:

Usual Medical Care

Treatment:

Other: Usual Care