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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
430
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.
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.
San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
San Antonio, Texas, United States
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, United States
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).
Time frame: Baseline to 6 months postpartum
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.
Time frame: Baseline (13 weeks gestational to delivery)
Birth Weight of Infant
Birth weight of the infant will be recorded in grams.
Time frame: Delivery
Length of Infant
Birth height of the infant will be recorded in centimeters.
Time frame: Delivery
Waist Circumference on Fitness Test Scores
Waist circumference will be recorded in centimeters.
Time frame: Baseline and 12 months postpartum
Number of Push Ups on Fitness Test Scores
Number of push ups completed.
Time frame: Baseline and 12 months postpartum
Number of Sit Ups on Fitness Test Scores
Number of sit ups completed.
Time frame: Baseline and 12 months postpartum
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
1.5 Mile Run on Fitness Test Scores
The amount of time it took to complete 1.5 miles.
Time frame: 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.
Time frame: 12 months postpartum