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Completed

NCT Number: NCT03057808

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

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.

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Key information

Conditions

Weight Gain Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Antonio Military Medical Center Obstetrics Clinic (SAMMC), San Antonio, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gestational weight gain intervention

Behavioral

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

Postpartum weight loss intervention

Behavioral

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

Primary outcomes

  1. Changes in the Mother's Body Weight Pre and Post Pregnancy

    Time frame: 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 outcomes

  1. Maternal and Fetal Conditions During Pregnancy

    Time frame: 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.

  2. Birth Weight of Infant

    Time frame: Delivery

    Birth weight of the infant will be recorded in grams.

  3. Length of Infant

    Time frame: Delivery

    Birth height of the infant will be recorded in centimeters.

  4. Waist Circumference on Fitness Test Scores

    Time frame: Baseline and 12 months postpartum

    Waist circumference will be recorded in centimeters.

  5. Number of Push Ups on Fitness Test Scores

    Time frame: Baseline and 12 months postpartum

    Number of push ups completed.

  6. Number of Sit Ups on Fitness Test Scores

    Time frame: Baseline and 12 months postpartum

    Number of sit ups completed.

  7. 1.5 Mile Run on Fitness Test Scores

    Time frame: Baseline and 12 months postpartum

    The amount of time it took to complete 1.5 miles.

  8. Moms Fit 2 Fight Program Evaluation Form

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • 59th Medical Wing
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • San Antonio Military Medical Center

Registry information

Official study title

Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Feb 20, 2017
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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