Recruiting

Observational Study

Sponsor:

Tripler Army Medical Center

Code:

NCT05518604

Conditions

Weight Loss

Postpartum Weight Retention

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

Interventions

Counseling with goal of modifying eating behaviors

Study Details

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.

Conditions

Weight Loss

Postpartum Weight Retention

Study ID

NCT05518604

Start date

Jan 22, 2024

Status verified date

Aug, 2025

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Accepted

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

Study Design

Enrollment

74 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm 1

Women in this arm will undergone dietary counseling in the first year postpartum in addition to close supervision of diet, exercise, and sleep.

experimental: Intervention Arm 2

Women in this arm will not have dietary counseling but will have close supervision of diet, exercise and sleep.

no intervention: Control

Women in this arm will undergo routine postpartum care.

Interventions

Counseling with goal of modifying eating behaviors

Dietary counseling will occur virtually a minimum of 4x and as desired by participant in the first year postpartum according to a standard protocol

Primary outcome measure

  • Return to required weight for active duty women at 12 weeks postpartum [ Time Frame: 12 weeks ]
  • Return to physical fitness at 12 months postpartum as assessed by physical fitness testing. [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Tripler Army Medical Center

Recruiting

Honolulu, Hawaii, United States, 96859

Desmond Doss Health Clinic

Recruiting

Schofield Barracks, Hawaii, United States, 96786

More Information

Sponsor

Tripler Army Medical Center

Last update posted

Sep 17, 2025

Last verified

Aug, 2025

Keywords

  • Weight loss
  • Exercise
  • Diet
  • Physical Fitness
  • Postpartum
  • Active Duty

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tripler Army Medical Center on 2025-09-17.