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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women

Conditions
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Weight Gain, Weight Loss

Intervention / Treatment
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* Behavioral: Gestational weight gain intervention
* Behavioral: Postpartum weight loss intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gestational weight gain intervention (GWG-only)<br>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. | Behavioral: Gestational weight gain intervention<br>* 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.<br>* Other names: GWG-only;|
| Experimental: Postpartum weight loss intervention (PPWL-only)<br>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. | Behavioral: Postpartum weight loss intervention<br>* 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.<br>* Other names: PPWL-only;|
| Experimental: Combined<br>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. | Behavioral: Gestational weight gain intervention<br>* 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.<br>* Other names: GWG-only;Behavioral: Postpartum weight loss intervention<br>* 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.<br>* Other names: PPWL-only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline to 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (13 weeks gestational to delivery) | 
| Birth Weight of Infant | Birth weight of the infant will be recorded in grams. | Delivery | 
| Length of Infant | Birth height of the infant will be recorded in centimeters. | Delivery | 
| Waist Circumference on Fitness Test Scores | Waist circumference will be recorded in centimeters. | Baseline and 12 months postpartum | 
| Number of Push Ups on Fitness Test Scores | Number of push ups completed. | Baseline and 12 months postpartum | 
| Number of Sit Ups on Fitness Test Scores | Number of sit ups completed. | Baseline and 12 months postpartum | 
| 1.5 Mile Run on Fitness Test Scores | The amount of time it took to complete 1.5 miles. | Baseline and 12 months postpartum | 
| 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. | 12 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Postpartum