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

Not Applicable

Completed

Conditions: Weight Gain
Weight Loss

Interventions: Behavioral: Gestational weight gain intervention
Behavioral: Postpartum weight loss intervention

Registration Number: NCT03057808

Lead Sponsor: University of Tennessee

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 430

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gestational weight gain intervention (GWG-only)	Gestational weight gain intervention	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.
Postpartum weight loss intervention (PPWL-only)	Postpartum weight loss intervention	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.
Combined	Gestational weight gain intervention	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.
Combined	Postpartum weight loss intervention	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.

Primary Outcome Measures

Name	Time	Method
Changes in the Mother's Body Weight Pre and Post Pregnancy	Baseline to 6 months postpartum	At all measurement visits, weight will be recorded in kilograms. Weight will be measured on a calibrated digital scale in duplicate, with the participant wearing light clothing and no shoes. While Investigators obtain the mother's weight at baseline, there will also be a self reported pregravid weight (before the last menstrual period).

Secondary Outcome Measures

Name	Time	Method
Maternal and Fetal Conditions During Pregnancy	Baseline (13 weeks gestational to delivery)	Pregnancy-related medical outcomes will be obtained from the participant's medical record and will include: maternal (e.g., gestational diabetes, preeclampsia) and fetal conditions.
Birth Weight of Infant	Delivery	Birth weight of the infant will be recorded in grams.
Length of Infant	Delivery	Birth height of the infant will be recorded in centimeters.
Waist Circumference on Fitness Test Scores	Baseline and 12 months postpartum	Waist circumference will be recorded in centimeters.
Number of Push Ups on Fitness Test Scores	Baseline and 12 months postpartum	Number of push ups completed.
Number of Sit Ups on Fitness Test Scores	Baseline and 12 months postpartum	Number of sit ups completed.
1.5 Mile Run on Fitness Test Scores	Baseline and 12 months postpartum	The amount of time it took to complete 1.5 miles.
Moms Fit 2 Fight Program Evaluation Form	12 months postpartum	Program satisfaction will be assessed using the Investigators program evaluation form to offer insight into program acceptability as well as barriers and facilitators to participation in each intervention arm. Participants will be given 10 statements to rate their experience using a 5 point scale.

Trial Locations

Locations (2): Wilford Hall Ambulatory Surgical Center
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San Antonio, Texas, United States
San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
🇺🇸
San Antonio, Texas, United States