Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)

University of Tennessee

Status: Completed

Conditions: Weight Loss; Weight Gain

Treatments: Behavioral: Gestational weight gain intervention; Behavioral: Postpartum weight loss intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT03057808

1R01DK104872-01A1 (U.S. NIH Grant/Contract)

16-04804-XP DOD

Details and patient eligibility

About

The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.

Full description

Investigators will randomize 450 consented participants to 1 of 3 interventions: a) a gestational weight gain intervention (GWG-only); b) a postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and postpartum weight loss intervention (GWG+PPWL) to determine the efficacy of the interventions on GWG as well as PPWL.

Procedures: Interested individuals will be directed to call the study telephone number to learn more and determine whether eligibility criteria is met. Individuals who meet the telephone screening eligibility criteria will be invited to schedule a Screening Visit, during which written informed consent will be obtained. At this visit, eligibility will be assessed and measures will be administrated. The potential participant will also be asked to complete a one-week dietary and exercise self-monitoring run-in and receive medical clearance from their obstetrician to participate. Should she continue to be interested, she will return for a Baseline Visit and will be randomized.

Randomized participants will have 5 in person scheduled visits after their Screening Visit and Baseline Visit to the Wilford Hall Ambulatory Surgical Center (WHASC) or San Antonio Military Medical Center (SAMMC) Obstetrics (OB) clinic. These visits will be scheduled at gestational week 32, 36, as well as at 6- weeks, 6-months, and 12- month postpartum. At these visits, physical measurements will be collected and participants will complete various questionnaires.

Enrollment: 430 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants will be active duty military, dependents or retired with TRICARE benefits
• Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC)
• Participants also must be within the normal, overweight, or obese BMI ranges
• Are generally in good health
• Currently not smoking more than 5 cigarettes per day at the time of conception

Exclusion criteria

• Expecting multiple babies (e.g. twins)
• Diabetic
• Not interested in participating in a program for 21 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 3 patient groups

Gestational weight gain intervention (GWG-only)

Experimental group

Description:

The GWG intervention will begin upon randomization to the GWG-only or the GWG+PPWL arm, and continue until the birth of the participant's child.

Treatment:

Behavioral: Gestational weight gain intervention

Postpartum weight loss intervention (PPWL-only)

Experimental group

Description:

The PPWL intervention will begin at 6-weeks postpartum (when most women will be approved for weight loss and exercise by their obstetrician) for those participants randomized to the PPWL only or the GWG+PPWL arms, and will continue until 6-months postpartum.

Treatment:

Behavioral: Postpartum weight loss intervention

Combined

Experimental group

Description:

During the gestational phase participants will receive the same intervention as the GWG only group. During the postpartum phase participants will receive the the same intervention as the PPWL group.

Treatment:

Behavioral: Postpartum weight loss intervention

Behavioral: Gestational weight gain intervention