Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)
NCT ID: NCT03057808
Last Updated: 2022-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
430 participants
INTERVENTIONAL
2017-02-06
2022-05-26
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Diabetic
* Not interested in participating in a program for 21 months
18 Years
FEMALE
Yes
Sponsors
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59th Medical Wing
FED
San Antonio Military Medical Center
FED
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Tennessee
OTHER
Responsible Party
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Principal Investigators
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Rebecca Krukowski, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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San Antonio Military Medical Center Obstetrics Clinic (SAMMC)
San Antonio, Texas, United States
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, United States
Countries
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References
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Solomon E, McPhail A, Bursac Z, Little MA, Talcott GW, Krukowski RA. Provider advice, pregnant persons' expectations, and actual gestational weight gain among United States military health care beneficiaries: a secondary analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Nov 25;24(1):785. doi: 10.1186/s12884-024-06987-x.
Perez-Munoz A, Hare ME, Andres A, Klesges RC, Wayne Talcott G, Little MA, Waters TM, Harvey JR, Bursac Z, Krukowski RA. A Postpartum Weight Loss-focused Stepped-care Intervention in a Military Population: A Randomized Controlled Trial. Ann Behav Med. 2023 Sep 13;57(10):836-845. doi: 10.1093/abm/kaad014.
Pebley K, Farage G, Hare ME, Bursac Z, Andres A, Chowdhury SMR, Talcott GW, Krukowski RA. Changes in self-reported and accelerometer-measured physical activity among pregnant TRICARE Beneficiaries. BMC Public Health. 2022 Nov 7;22(1):2029. doi: 10.1186/s12889-022-14457-2.
Estevez Burns R, Hare ME, Andres A, Klesges RC, Talcott GW, LeRoy K, Little MA, Hyrshko-Mullen A, Waters TM, Harvey JR, Bursac Z, Krukowski RA. An interim analysis of a gestational weight gain intervention in military personnel and other TRICARE beneficiaries. Obesity (Silver Spring). 2022 Oct;30(10):1951-1962. doi: 10.1002/oby.23523. Epub 2022 Aug 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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16-04804-XP DOD
Identifier Type: -
Identifier Source: org_study_id