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

Weight Loss Clinical Trial

Official title:

Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03057808
• Other study ID #: 16-04804-XP DOD
• Secondary ID: 1R01DK104872-01A
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: May 26, 2022

Study information

• Verified date: July 2022
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: May 26, 2022
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Gestational Weight Gain
• Weight Gain
• Weight Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	San Antonio Military Medical Center Obstetrics Clinic (SAMMC)	San Antonio	Texas
United States	Wilford Hall Ambulatory Surgical Center	San Antonio	Texas

Sponsors (5)

Lead Sponsor	Collaborator
University of Tennessee	59th Medical Wing, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), San Antonio Military Medical Center, University of Tennessee Health Science Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Birth Weight of Infant	Birth weight of the infant will be recorded in grams.	Delivery
Secondary	Length of Infant	Birth height of the infant will be recorded in centimeters.	Delivery
Secondary	Waist Circumference on Fitness Test Scores	Waist circumference will be recorded in centimeters.	Baseline and 12 months postpartum
Secondary	Number of Push Ups on Fitness Test Scores	Number of push ups completed.	Baseline and 12 months postpartum
Secondary	Number of Sit Ups on Fitness Test Scores	Number of sit ups completed.	Baseline and 12 months postpartum
Secondary	1.5 Mile Run on Fitness Test Scores	The amount of time it took to complete 1.5 miles.	Baseline and 12 months postpartum
Secondary	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