N/A
N=430
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)
Weight Gain · Weight Loss
Bottom Line
View on ClinicalTrials.gov: NCT03057808 ↗Enrolled (actual)
430
Serious AEs
13.5%
Results posted
Dec 2022
Primary outcome: Primary: Changes in the Mother's Body Weight Pre and Post Pregnancy — 2.39; 1.25; 1.37 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gestational weight gain intervention (Behavioral); Postpartum weight loss intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Tennessee
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Mother's Body Weight Pre and Post Pregnancy |
2.39; 1.25; 1.37 | — |
| SECONDARY Maternal and Fetal Conditions During Pregnancy |
22; 13; 35; 26; 17; 13 | — |
| SECONDARY Birth Weight of Infant |
3363.5; 3365.3 | — |
| SECONDARY Length of Infant |
51.3; 50.8 | — |
| SECONDARY Waist Circumference on Fitness Test Scores |
— | — |
| SECONDARY Number of Push Ups on Fitness Test Scores |
— | — |
| SECONDARY Number of Sit Ups on Fitness Test Scores |
— | — |
| SECONDARY 1.5 Mile Run on Fitness Test Scores |
— | — |
| SECONDARY Moms Fit 2 Fight Program Evaluation Form |
96; 88; 93; 95; 87; 96 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03057808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.