Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women

NCT05518604 | Recruiting

• 1 other identifier: 22-15411
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Return to required weight for active duty women at 12 weeks postpartum

  Primary outcome is the number of active duty women who are able to return to required weight at 12 weeks following delivery

  12 weeks

• Return to physical fitness at 12 months postpartum as assessed by physical fitness testing.

  Secondary outcome is the number of active duty women who pass their physical fitness assessment at 1 year postpartum. This assessment includes weight and physical fitness

  12 months

Study Arms (3)

Intervention Arm 1

EXPERIMENTAL

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

Behavioral: Counseling with goal of modifying eating behaviors

Intervention Arm 2

EXPERIMENTAL

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

Behavioral: Counseling with goal of modifying eating behaviors

Control

NO INTERVENTION

Women in this arm will undergo routine postpartum care.

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

Intervention Arm 1; Intervention Arm 2

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Must be female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Active Duty from any service - Army, Navy, Air Force, Marine, Coast Guard.
• Any rank
• Singleton Pregnancy
• Delivery between 36weeks and 41weeks EGA
• Non obese (\<30BMI) at NOB appointment in 1st trimester.
• Any type of delivery (spontaneous vaginal delivery, operative vaginal delivery, cesarean delivery)
• First term pregnancy
• Live birth
• Must have documented standardized fitness evaluation for record prior to pregnancy
• Must have plan to remain on AD for a minimum of 18 months following delivery.
• Not planning short interval pregnancy within 18 months of delivery
• Must be planning on staying on Oahu for a minimum of 12 months following delivery

You may not qualify if:

• Obese ( \> 30 BMI) at NOB appointment in 1st trimester
• Delivery before 36 weeks
• Severe maternal morbidity requiring prolonged ( \> 1week) postpartum admission
• NICU admission \> 2 week
• Profile beyond pregnancy profile limiting ability to exercise or take physical fitness exam.
• Desires to take a leave of duty or separation from duty in the first 18 months following pregnancy
• No physical fitness test for record in the year prior to pregnancy.
• Prior pregnancy beyond 20 weeks
• Planning future pregnancy within 18 months of delivery

Sponsors & Collaborators

• Tripler Army Medical Center: lead

Study Sites (2)

Tripler Army Medical Center

Honolulu, Hawaii, 96859, United States

RECRUITING

Desmond Doss Health Clinic

Schofield Barracks, Hawaii, 96786, United States

RECRUITING

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MeSH Terms

Conditions

Weight Loss; Gestational Weight Gain; Motor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Gain; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Alan P Gehrich, MD

  Tripler Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan P Gehrich, MD

CONTACT

(808) 433-6621; alan.p.gehrich.civ@mail.mil

Chothika Mekonnen, BS

CONTACT

(808) 433-7171; chothika.mekonnen.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician and Gynecologist, Urogynecologist, Minimally Invasive Gynecologic Surgeon

Model Details: Active Duty women will be enrolled during pregnancy and randomized postpartum to one of three groups for the first year postpartum. Group 1- dietary counseling with close monitoring utilizing a biometric fitness device Group 2- Close monitoring with biometric fitness device Group 3 Routine postpartum care

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: January 22, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)