NCT05518604 Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women
| NCT ID | NCT05518604 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tripler Army Medical Center |
| Condition | Weight Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 74 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 74 participants in total. It began in 2024-01-22 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Active Duty from any service - Army, Navy, Air Force, Marine, Coast Guard. 2. Any rank 3. Singleton Pregnancy 4. Delivery between 36weeks and 41weeks EGA 5. Non obese (\<30BMI) at NOB appointment in 1st trimester. 6. Any type of delivery (spontaneous vaginal delivery, operative vaginal delivery, cesarean delivery) 7. First term pregnancy 8. Live birth 9. Must have documented standardized fitness evaluation for record prior to pregnancy 10. Must have plan to remain on AD for a minimum of 18 months following delivery. 11. Not planning short interval pregnancy within 18 months of delivery 12. Must be planning on staying on Oahu for a minimum of 12 months following delivery Exclusion Criteria: 1. Obese ( \> 30 BMI) at NOB appointment in 1st trimester 2. Delivery before 36 weeks 3. Severe maternal morbidity requiring prolonged ( \> 1week) postpartum admission 4. NICU admission \> 2 week 5. Profile beyond pregnancy profile limiting ability to exercise or take physical fitness exam. 6. Desires to take a leave of duty or separation from duty in the first 18 months following pregnancy 7. No physical fitness test for record in the year prior to pregnancy. 8. Prior pregnancy beyond 20 weeks 9. Planning future pregnancy within 18 months of delivery
Contact & Investigator
Alan P Gehrich, MD
PRINCIPAL INVESTIGATOR
Tripler Army Medical Center
Frequently Asked Questions
Who can join the NCT05518604 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 44 Years, studying Weight Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05518604 currently recruiting?
Yes, NCT05518604 is actively recruiting participants. Contact the research team at alan.p.gehrich.civ@mail.mil for enrollment information.
Where is the NCT05518604 trial being conducted?
This trial is being conducted at Honolulu, United States, Schofield Barracks, United States.
Who is sponsoring the NCT05518604 clinical trial?
NCT05518604 is sponsored by Tripler Army Medical Center. The principal investigator is Alan P Gehrich, MD at Tripler Army Medical Center. The trial plans to enroll 74 participants.