Practical Approaches to Exercise in Moms
Overview
- Phase
- Phase 1
- Sponsor
- Maxine Mendelson
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change in baseline body weight at 12-months postpartum.
Overview
Brief Summary
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.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Change in baseline body weight at 12-months postpartum.
Time Frame: Baseline and 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Maxine Mendelson
Clinical Research Coordinator
Nationwide Children's Hospital