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

Sponsor

University of Tennessee (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03057808

Collaborator

59th Medical Wing (U.S. Fed), San Antonio Military Medical Center (U.S. Fed), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), University of Tennessee Health Science Center (Other)

450

Enrollment

Locations

Arms

62.7

Anticipated Duration (Months)

225

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Gain Weight Loss	Behavioral: Gestational weight gain intervention Behavioral: Postpartum weight loss intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women

Actual Study Start Date :

Feb 6, 2017

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Apr 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gestational weight gain intervention (GWG-only) 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 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. Other Names: GWG-only
Experimental: Postpartum weight loss intervention (PPWL-only) 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 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. Other Names: PPWL-only
Experimental: Combined 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 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. Other Names: GWG-only Behavioral: Postpartum weight loss intervention 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. Other Names: PPWL-only

Arm

Intervention/Treatment

Experimental: Gestational weight gain intervention (GWG-only)

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

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.

Other Names:

GWG-only

Experimental: Postpartum weight loss intervention (PPWL-only)

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

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.

Other Names:

PPWL-only

Experimental: Combined

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

Other Names:

GWG-only

Behavioral: Postpartum weight loss intervention

Other Names:

PPWL-only

Outcome Measures

Primary Outcome Measures

Changes in the mother's body weight pre and post pregnancy [Baseline to 6 months postpartum]
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).

Secondary Outcome Measures

Maternal and Fetal Conditions during pregnancy [Baseline (13 weeks gestational to delivery)]
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.
Birth Weight of Infant [Delivery]
Birth weight of the infant will be recorded in kilograms.
Length of Infant [Delivery]
Birth height of the infant will be recorded in centimeters.
Waist Circumference on Fitness Test Scores [Baseline and 12 months postpartum]
Waist circumference will be recorded in centimeters.
Number of Push Ups on Fitness Test Scores [Baseline and 12 months postpartum]
Number of push ups completed.
Number of Sit ups on Fitness Test Scores [Baseline and 12 months postpartum]
Number of sit ups completed.
1.5 mile run on Fitness Test Scores [Baseline and 12 months postpartum]
The amount of time it took to complete 1.5 miles.
Program Evaluation Form [32 weeks gestation and 6 months postpartum]
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 of 1 being not at all and 5 being extremely. In addition, there will be four qualitative questions where the participant can provide feedback.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Antonio Military Medical Center Obstetrics Clinic (SAMMC)	San Antonio	Texas	United States	78219
2	Wilford Hall Ambulatory Surgical Center	San Antonio	Texas	United States	78236