Practical Approaches to Exercise in Moms (PE Moms)

Maxine Mendelson

Status and phase: Unknown; Phase 1

Conditions: Body Weight

Treatments: Device: Ankle weights; Device: Fitbit activity tracker

Study type: Interventional

Funder types: Other

Identifiers

NCT02516865

IRB15-00117

Details and patient eligibility

About

This project aims to test the feasibility of a practical physical activity intervention for postpartum women, incorporating the use of body weights worn during typical daily activities.

Full description

We are piloting a 3-arm, unblinded, randomized controlled trial in postpartum women; with 10 participants in each study group. Women will be recruited at 2-6 months postpartum, with the intervention lasting through 12 months postpartum. Data collection will include:1) Physical activity; 2) Maternal body composition; 3) Questionnaires to assess:motivation to adopt healthy behaviors, body attitudes, infant feeding practices; 4) Process evaluation to assess: likes and dislikes about the intervention program, suggestions for improving the intervention, reasons for leaving the study. The proposed study time period is 6 months for study recruitment, 18 months to carry out the study, and 6 months for data analysis (total 2 years).

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 2-6 months postpartum women

Exclusion criteria

• Premature birth
• History of serious illness
• Medically incapable of low-intensity exercise
• Currently taking medications that cause weight loss

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Group 1

Experimental group

Treatment:

Device: Fitbit activity tracker

Group 2

Experimental group

Treatment:

Device: Fitbit activity tracker

Device: Ankle weights

Group 3

No Intervention group