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Recruiting Not applicable Interventional Accepts healthy volunteers

Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women

ClinicalTrials.gov ID: NCT05518604

Public ClinicalTrials.gov record NCT05518604. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 11:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05518604
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Tripler Army Medical Center
Federal
Enrollment
74 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 44 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 21, 2024
Primary completion
Nov 30, 2026
Completion
Apr 30, 2027
Last update posted
Sep 16, 2025

2024 – 2027

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Tripler Army Medical Center Honolulu Hawaii 96859 Recruiting
Desmond Doss Health Clinic Schofield Barracks Hawaii 96786 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05518604, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 16, 2025 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05518604 live on ClinicalTrials.gov.

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