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

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ClinicalTrials.gov Identifier: NCT03057808
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborators:
Wilford Hall Ambulatory Surgical Center
San Antonio Military Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Tennessee Health Science Center
Information provided by (Responsible Party):
University of Tennessee

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : February 6, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: PPWL-only




Primary Outcome Measures :
  1. Changes in the mother's body weight pre and post pregnancy [ Time Frame: 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 :
  1. Maternal and Fetal Conditions during pregnancy [ Time Frame: 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.

  2. Birth Weight of Infant [ Time Frame: Delivery ]
    Birth weight of the infant will be recorded in kilograms.

  3. Length of Infant [ Time Frame: Delivery ]
    Birth height of the infant will be recorded in centimeters.

  4. Waist Circumference on Fitness Test Scores [ Time Frame: Baseline and 12 months postpartum ]
    Waist circumference will be recorded in centimeters.

  5. Number of Push Ups on Fitness Test Scores [ Time Frame: Baseline and 12 months postpartum ]
    Number of push ups completed.

  6. Number of Sit ups on Fitness Test Scores [ Time Frame: Baseline and 12 months postpartum ]
    Number of sit ups completed.

  7. 1.5 mile run on Fitness Test Scores [ Time Frame: Baseline and 12 months postpartum ]
    The amount of time it took to complete 1.5 miles.

  8. Program Evaluation Form [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057808


Contacts
Contact: Rebecca Krukowski, PhD 9014482426 rkrukows@uthsc.edu
Contact: Karen Leroy, RN 210-292-3504 kml4s@virginia.edu

Locations
United States, Texas
San Antonio Military Medical Center Obstetrics Clinic (SAMMC) Recruiting
San Antonio, Texas, United States, 78219
Contact: Leslie Gladney, M.S.    210-413-5946    mf2f@uthsc.edu   
Contact: Karen Leroy, RN    210-292-3504    kml4s@virginia.edu   
Wilford Hall Ambulatory Surgical Center Recruiting
San Antonio, Texas, United States, 78236
Contact: Leslie Gladney, MS    210-413-5946    mf2f@uthsc.edu   
Contact: Karen Leroy, RN    210 292 3504    kml4s@virginia.edu   
Sponsors and Collaborators
University of Tennessee
Wilford Hall Ambulatory Surgical Center
San Antonio Military Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Tennessee Health Science Center
Investigators
Principal Investigator: Rebecca Krukowski, PhD University of Tennessee Health Science Center

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT03057808     History of Changes
Other Study ID Numbers: 16-04804-XP DOD
1R01DK104872-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Tennessee:
Pregnancy
Postpartum

Additional relevant MeSH terms:
Body Weight
Weight Loss
Weight Gain
Signs and Symptoms
Body Weight Changes