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Dietary Intervention for Postpartum Weight Retention (PADaWL Trial)

N/A

Waitlist Available

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

PADaWL Trial 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.Check my eligibility

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.See study design

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.

PADaWL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

PADaWL 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.

Do I qualify?Apply below to find out

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

Weight Loss Research Study Groups: Intervention Arm 1, Intervention Arm 2, Control

Weight Loss 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this research endeavor at the present time?

"Clinicaltrials.gov states that this research initiative is not presently seeking enrolment, as the trial was initially posted on January 1st 2023 and last revised on August 24th 2022. Despite its current inactivity, there are still over 300 trials actively recruiting participants."

Answered by AI

Could I potentially qualify for inclusion in this research endeavor?

"To participate in this medical research, candidates must be aged between 18 and 44 years old and have experienced some degree of weight loss. The team is looking to recruit approximately 64 individuals for the clinical trial."

Answered by AI