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Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women

Study acronym: PADaWL
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary completion date: Oct 1, 2025 to Dec 1, 2026
    • Study completion date: May 1, 2026 to May 1, 2027
    • Study description expanded, about 66 words
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2023 to Jan 22, 2024
    • Study sites: 1 to 2
    • Primary completion date: May 1, 2025 to Oct 1, 2025
    • Study completion date: Jan 1, 2026 to May 1, 2026
  3. Notable Start date: Jan 1, 2023 to Aug 1, 2023
    • Enrollment target: 64 to 74
    • Primary completion date: Jan 1, 2025 to May 1, 2025
    • Study arms: 2 to 3
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pregnancy and delivery are major stressors on the female body and contribute significantly to permanent weight gain and associated morbidity in women. This can profoundly affect the ability of active duty (AD) women to advance in their career. The first 12 weeks postpartum are the time period during which the most significant weight loss occurs and is critical in achieving a healthy weight in the first year postpartum. Many factors contribute to effective weight loss in this period among which the most critical are diet, exercise, and sleep. Breast feeding and depression may also affect weight changes postpartum. Research has shown diet to likely be the most crucial of these factors. The PADaWL study is designed as a randomized controlled trial to assess the effects of dietary intervention on weight and physical fitness versus routine postpartum care in the first year postpartum. Subjects will be primiparous AD women from any military service recruited in the obstetric clinic in the third trimester of pregnancy at Tripler Army Medical Center. Data will collected in an ambi-directional fashion with pre-pregnancy physical fitness data, demographic and pregnancy data collected at time of enrollment. Subjects will be randomized to receive intensive virtual sessions with a dietician vs routine postpartum care for the first 12 months postpartum. We will utilize a biometric device to monitor activity levels and sleep, web-based diaries to monitor breast feeding and diet, and validated questionnaires to evaluate depression as well as diet and sleep. Subjects will be monitored weekly for the first 12 weeks postpartum and will then be further evaluated at 6, 9 and 12 months postpartum. Primary outcome is weight at 12weeks postpartum and whether subjects have achieved military standards. Secondary outcome will be weight at 12 months postpartum and whether subject has achieved weight and fitness standards. The study intends to collect large amounts of data, and we intend to analyze which factors may be contributing to weight retention postpartum. This study should provide an accurate assessment of the effects of pregnancy on AD women. It should generate a clean and accurate dataset on which multiple follow-on studies can be performed and provide data for designing further intervention studies in postpartum women. The results of this study should also be able to assist in developing policy and guidance concerning AD women and pregnancy.
Trial Details
NCT Number NCT05518604
Lead Sponsor Tripler Army Medical Center
Conditions
(from sponsor)
Weight Loss, Postpartum Weight Retention
Related terms Gestational Weight Gain, Motor Activity, Weight Loss
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov