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NCT05518604 · ClinicalTrials.gov registry record · NA
Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women
A NA study of Weight Loss and Postpartum Weight Retention, sponsored by Tripler Army Medical Center.
- Recruiting
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 2
- Study locations
NCT05518604: Recruiting NA study of Weight Loss and Postpartum Weight Retention, sponsored by Tripler Army Medical Center.
NCT05518604 is a NA study of Weight Loss and Postpartum Weight Retention that is actively recruiting participants, run by Tripler Army Medical Center. The registered enrollment target is 74 participants, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05518604, a NA study of Weight Loss and Postpartum Weight Retention, is actively recruiting participants, sponsored by Tripler Army Medical Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 2
- Study locations
Study 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 a
Primary Outcome
Primary outcome is the number of active duty women who are able to return to required weight at 12 weeks following delivery
Conditions Studied
Interventions
- BEHAVIORAL Counseling with goal of modifying eating behaviors
Study Locations (2)
Hawaii
- Tripler Army Medical Center - Honolulu
- Desmond Doss Health Clinic - Schofield Barracks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2024-01-22 |
| Est. Completion | 2027-05-01 |
| Phase | NA |
What NCT05518604 shows while recruiting
NCT05518604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Weight Loss appearing as the primary indexed condition, and to 1 intervention - of which Counseling with goal of modifying eating behaviors is the first listed.
NCT05518604 reports a single indexed study location in Hawaii.
Frequently Asked Questions
What is clinical trial NCT05518604 about?
NCT05518604 is a clinical study titled "Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women". 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...
What is the current status of trial NCT05518604?
This trial is currently recruiting. It is a NA study. The enrollment target is 74 participants. The study started on 2024-01-22. Estimated completion is 2027-05-01.
What conditions does trial NCT05518604 study?
This clinical trial studies the following conditions: Weight Loss, Postpartum Weight Retention.
What interventions are being tested in trial NCT05518604?
The interventions under investigation include: Counseling with goal of modifying eating behaviors (BEHAVIORAL).
Who is sponsoring clinical trial NCT05518604?
This trial is sponsored by Tripler Army Medical Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05518604 being conducted?
This trial has 2 study locations across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05518604's enrollment target sits among peer trials
74 62nd of 116 higher than 55 of 116 other Weight Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Weight Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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