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

Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Weight Gain
• Intervention / Treatment: Behavioral: Gestational weight gain intervention; Behavioral: Postpartum weight loss intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78219
      • San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
    • San Antonio, Texas, United States, 78236
      • Wilford Hall Ambulatory Surgical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gestational weight gain intervention (GWG-only); 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.	Behavioral: Gestational weight gain intervention; This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.; Other Names: GWG-only
Experimental: Postpartum weight loss intervention (PPWL-only); 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.	Behavioral: Postpartum weight loss intervention; The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.; Other Names: PPWL-only
Experimental: Combined; 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.	Behavioral: Gestational weight gain intervention; This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.; Other Names: GWG-only; Behavioral: Postpartum weight loss intervention; The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.; Other Names: PPWL-only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Mother's Body Weight Pre and Post Pregnancy	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).	Baseline to 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Infant	Birth height of the infant will be recorded in centimeters.	Delivery
Waist Circumference on Fitness Test Scores	Waist circumference will be recorded in centimeters.	Baseline and 12 months postpartum
Number of Push Ups on Fitness Test Scores	Number of push ups completed.	Baseline and 12 months postpartum
Maternal and Fetal Conditions During Pregnancy	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.	Baseline (13 weeks gestational to delivery)
Birth Weight of Infant	Birth weight of the infant will be recorded in grams.	Delivery
Number of Sit Ups on Fitness Test Scores	Number of sit ups completed.	Baseline and 12 months postpartum
1.5 Mile Run on Fitness Test Scores	The amount of time it took to complete 1.5 miles.	Baseline and 12 months postpartum
Moms Fit 2 Fight Program Evaluation Form	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.	12 months postpartum

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); 59th Medical Wing; San Antonio Military Medical Center; University of Tennessee Health Science Center

Publications and helpful links

General Publications

• Pebley K, Farage G, Hare ME, Bursac Z, Andres A, Chowdhury SMR, Talcott GW, Krukowski RA. Changes in self-reported and accelerometer-measured physical activity among pregnant TRICARE Beneficiaries. BMC Public Health. 2022 Nov 7;22(1):2029. doi: 10.1186/s12889-022-14457-2.
• Estevez Burns R, Hare ME, Andres A, Klesges RC, Talcott GW, LeRoy K, Little MA, Hyrshko-Mullen A, Waters TM, Harvey JR, Bursac Z, Krukowski RA. An interim analysis of a gestational weight gain intervention in military personnel and other TRICARE beneficiaries. Obesity (Silver Spring). 2022 Oct;30(10):1951-1962. doi: 10.1002/oby.23523. Epub 2022 Aug 30.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): May 26, 2022

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: February 15, 2017
• First Posted (Actual): February 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum
• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight; Weight Gain; Gestational Weight Gain
• Other Study ID Numbers: 16-04804-XP DOD; 1R01DK104872-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No