Intervention Arm for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tripler Army Medical Center, Honolulu, HI
Weight Loss+4 More
Counseling with goal of modifying eating behaviors - Behavioral
Eligibility
18 - 65
Female
What conditions do you have?
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Study 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.

Eligible Conditions

  • Weight Loss
  • Postnatal Care

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Return to physical fitness at 12 months postpartum as assessed by physical fitness testing.
12 weeks
Return to required weight for active duty women at 12 weeks postpartum

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Arm
1 of 2
Intervention Arm
1 of 2
Active Control
Experimental Treatment

64 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention Arm · No Placebo Group · N/A

Intervention Arm
Behavioral
Experimental Group · 1 Intervention: Counseling with goal of modifying eating behaviors · Intervention Types: Behavioral
Control ArmNoIntervention Group · 1 Intervention: Control Arm · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Tripler Army Medical Center · Honolulu, HI
Photo of hawaii 1Photo of hawaii 2Photo of hawaii 3
2011First Recorded Clinical Trial
3 TrialsResearching Weight Loss
119 CompletedClinical Trials

Who is running the clinical trial?

Tripler Army Medical CenterLead Sponsor
20 Previous Clinical Trials
27,925 Total Patients Enrolled
Alan P Gehrich, MDPrincipal InvestigatorTripler Army Medical Center

Eligibility Criteria

Age 18 - 65 · Female Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are non obese (<30BMI) at NOB appointment in 1st trimester.
You must have a plan to remain on AD for a minimum of 18 months following delivery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References