Weight loss and fitness program for active duty women after pregnancy
Pregnancy, Active Duty and Weight Loss (PADaWL) Study: A Randomized Controlled Trial Assessing the Effect of Dietary Intervention on Postpartum Weight Loss in Active Duty Women
This study is testing if a special diet plan can help active duty women who just had a baby lose weight and get fit during their first year after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Tripler Army Medical Center Federal |
| Locations | 2 sites (Honolulu, Hawaii and 1 other locations) |
| Trial ID | NCT05518604 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a dietary intervention on weight loss and physical fitness in active duty women during the first year postpartum. Participants will be randomly assigned to receive either dietary counseling focused on modifying eating behaviors or routine postpartum care. The study targets primiparous women from any military service who have recently given birth, with a focus on addressing postpartum weight retention and its associated health risks. The trial will assess changes in weight and fitness levels over the course of the year following delivery.
Who should consider this trial
Good fit: Ideal candidates for this study are active duty women who have recently given birth and are not obese at the time of their first trimester appointment.
Not a fit: Patients who are obese prior to pregnancy or those with severe maternal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could help active duty women achieve a healthier weight and improve their physical fitness postpartum, potentially enhancing their career progression and overall well-being.
How similar studies have performed: Other studies have shown success in dietary interventions for postpartum weight loss, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Honolulu, Hawaii and 1 other locations
- Tripler Army Medical Center — Honolulu, Hawaii, United States (Recruiting)
- Desmond Doss Health Clinic — Schofield Barracks, Hawaii, United States (Recruiting)
Study contacts
- Principal investigator: Alan P Gehrich, MD — Tripler Army Medical Center
- Study coordinator: Alan P Gehrich, MD
- Email: alan.p.gehrich.civ@mail.mil
- Phone: (808) 433-6621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.