Clinical trial NCT03057808: 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
Overall status: COMPLETED
Phase: NA
Conditions: Weight Gain
Weight Loss
Keywords: Pregnancy
Postpartum
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: 59th Medical Wing
name: San Antonio Military Medical Center
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-02-20
Enrollment: 430
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in the Mother's Body Weight Pre and Post Pregnancy
timeFrame: Baseline to 6 months postpartum
Secondary outcomes:
measure: Maternal and Fetal Conditions During Pregnancy
timeFrame: Baseline (13 weeks gestational to delivery)
measure: Birth Weight of Infant
timeFrame: Delivery
measure: Length of Infant
timeFrame: Delivery
measure: Waist Circumference on Fitness Test Scores
timeFrame: Baseline and 12 months postpartum
measure: Number of Push Ups on Fitness Test Scores
timeFrame: Baseline and 12 months postpartum
measure: Number of Sit Ups on Fitness Test Scores
timeFrame: Baseline and 12 months postpartum
measure: 1.5 Mile Run on Fitness Test Scores
timeFrame: Baseline and 12 months postpartum
measure: Moms Fit 2 Fight Program Evaluation Form
timeFrame: 12 months postpartum
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
Study officials:
affiliation: University of Tennessee
name: Rebecca Krukowski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.