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Dietary Intervention for Postpartum Weight Retention (PADaWL Trial)

N/A
Recruiting
Led By Alan P Gehrich, MD
Research Sponsored by Tripler Army Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to assess the effects of dietary intervention on weight and physical fitness versus routine postpartum care in the first year postpartum for active duty women.

Who is the study for?
This trial is for active duty women from any military service who are experiencing their first pregnancy, have a BMI under 30 in the first trimester, and plan to remain on active duty for at least 18 months post-delivery. They must not be planning another pregnancy within that time and should stay on Oahu for at least 12 months after giving birth.
What is being tested?
The study tests if counseling with a dietician can help new mothers return to pre-pregnancy weight and meet military fitness standards faster than usual care. Participants will get weekly virtual sessions with a dietician for the first year postpartum, alongside monitoring of activity levels, sleep, breastfeeding habits, diet, and depression.
What are the potential side effects?
There may not be direct side effects from the interventions as they involve dietary counseling rather than medication or medical procedures. However, changes in diet or exercise routines could lead to fatigue or digestive adjustments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Return to physical fitness at 12 months postpartum as assessed by physical fitness testing.
Return to required weight for active duty women at 12 weeks postpartum

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm 2Experimental Treatment1 Intervention
Women in this arm will not have dietary counseling but will have close supervision of diet, exercise and sleep.
Group II: Intervention Arm 1Experimental Treatment1 Intervention
Women in this arm will undergone dietary counseling in the first year postpartum in addition to close supervision of diet, exercise, and sleep.
Group III: ControlActive Control1 Intervention
Women in this arm will undergo routine postpartum care.

Find a Location

Who is running the clinical trial?

Tripler Army Medical CenterLead Sponsor
20 Previous Clinical Trials
27,575 Total Patients Enrolled
Alan P Gehrich, MDPrincipal InvestigatorTripler Army Medical Center

Media Library

Counseling with goal of modifying eating behaviors Clinical Trial Eligibility Overview. Trial Name: NCT05518604 — N/A
Obesity Research Study Groups: Intervention Arm 1, Intervention Arm 2, Control
Obesity Clinical Trial 2023: Counseling with goal of modifying eating behaviors Highlights & Side Effects. Trial Name: NCT05518604 — N/A
Counseling with goal of modifying eating behaviors 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518604 — N/A
~37 spots leftby Oct 2025
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