Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Tripler Army Medical Center
Study ID
NCT05518604
Status
Recruiting
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Conditions

  • Postpartum Weight Retention
  • Weight Loss

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • Counseling with goal of modifying eating behaviors — BEHAVIORAL
    Dietary counseling will occur virtually a minimum of 4x and as desired by participant in the first year postpartum according to a standard protocol

Study Details

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.

Key Dates

Start date
Jan 22, 2024
Status verified
Aug 2025
Primary completion
Dec 1, 2026
Completion
May 1, 2027

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Return to required weight for active duty women at 12 weeks postpartum [ Time Frame: 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tripler Army Medical CenterHonoluluHawaii96859-
Desmond Doss Health ClinicSchofield BarracksHawaii96786-

Find similar trials in Honolulu, HI

By research site
Tripler Army Medical Center· Honolulu, HIDesmond Doss Health Clinic· Schofield Barracks, HI

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