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

Primary Purpose

Weight Gain, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gestational weight gain intervention
Postpartum weight loss intervention
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Gain focused on measuring Pregnancy, Postpartum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

  • San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
  • Wilford Hall Ambulatory Surgical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Gestational weight gain intervention (GWG-only)

Postpartum weight loss intervention (PPWL-only)

Combined

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Birth Weight of Infant
Birth weight of the infant will be recorded in grams.
Length of Infant
Birth height of the infant will be recorded in centimeters.
Waist Circumference on Fitness Test Scores
Waist circumference will be recorded in centimeters.
Number of Push Ups on Fitness Test Scores
Number of push ups completed.
Number of Sit Ups on Fitness Test Scores
Number of sit ups completed.
1.5 Mile Run on Fitness Test Scores
The amount of time it took to complete 1.5 miles.
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.

Full Information

First Posted
January 3, 2017
Last Updated
December 2, 2022
Sponsor
University of Tennessee
Collaborators
59th Medical Wing, San Antonio Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03057808
Brief Title
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)
Official Title
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 6, 2017 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
May 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
Collaborators
59th Medical Wing, San Antonio Military Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Weight Loss
Keywords
Pregnancy, Postpartum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gestational weight gain intervention (GWG-only)
Arm Type
Experimental
Arm 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.
Arm Title
Postpartum weight loss intervention (PPWL-only)
Arm Type
Experimental
Arm 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.
Arm Title
Combined
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Gestational weight gain intervention
Other Intervention Name(s)
GWG-only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Postpartum weight loss intervention
Other Intervention Name(s)
PPWL-only
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in the Mother's Body Weight Pre and Post Pregnancy
Description
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).
Time Frame
Baseline to 6 months postpartum
Secondary Outcome Measure Information:
Title
Maternal and Fetal Conditions During Pregnancy
Description
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.
Time Frame
Baseline (13 weeks gestational to delivery)
Title
Birth Weight of Infant
Description
Birth weight of the infant will be recorded in grams.
Time Frame
Delivery
Title
Length of Infant
Description
Birth height of the infant will be recorded in centimeters.
Time Frame
Delivery
Title
Waist Circumference on Fitness Test Scores
Description
Waist circumference will be recorded in centimeters.
Time Frame
Baseline and 12 months postpartum
Title
Number of Push Ups on Fitness Test Scores
Description
Number of push ups completed.
Time Frame
Baseline and 12 months postpartum
Title
Number of Sit Ups on Fitness Test Scores
Description
Number of sit ups completed.
Time Frame
Baseline and 12 months postpartum
Title
1.5 Mile Run on Fitness Test Scores
Description
The amount of time it took to complete 1.5 miles.
Time Frame
Baseline and 12 months postpartum
Title
Moms Fit 2 Fight Program Evaluation Form
Description
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.
Time Frame
12 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Krukowski, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78219
Country
United States
Facility Name
Wilford Hall Ambulatory Surgical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78236
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36336697
Citation
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.
Results Reference
derived
PubMed Identifier
36041980
Citation
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.
Results Reference
derived

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

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