Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)
Status: | Recruiting |
---|---|
Conditions: | Obesity Weight Loss, Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/12/2018 |
Start Date: | February 6, 2017 |
End Date: | August 2021 |
Contact: | Rebecca Krukowski, PhD |
Email: | rkrukows@uthsc.edu |
Phone: | 9014482426 |
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women
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.
weight management program is successful in helping TRICARE beneficiaries who are pregnant or
post-partum to manage their weight during and after their pregnancy.
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.
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.
Inclusion Criteria:
- Participants will be active duty military, dependents or retired with TRICARE benefits
, living in the San Antonio, TX area
- 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
- Must expect to remain living in the San Antonio, TX area for at least 1.5 years
- 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
We found this trial at
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sites
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San Antonio, Texas 78219
Phone: 210-413-5946
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