Weight Loss and Physical Fitness Following Pregnancy in Active Duty Women

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorTripler Army Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Active Duty from any service - Army, Navy, Air Force, Marine, Coast Guard.

Any rank

Singleton Pregnancy

Delivery between 36weeks and 41weeks EGA

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

74 Participants
are divided into 3 treatment groups
Group A: Intervention Arm 1Experimental treatment 1 intervention
Group B: Intervention Arm 2Experimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks
2

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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