MedPath

Practical Approaches to Exercise in Moms

Phase 1
Conditions
Body Weight
Interventions
Device: Fitbit activity tracker
Device: Ankle weights
Registration Number
NCT02516865
Lead Sponsor
Maxine Mendelson
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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
30
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Group 2Fitbit activity tracker-
Group 1Fitbit activity tracker-
Group 2Ankle weights-
Primary Outcome Measures
NameTimeMethod
Change in baseline body weight at 12-months postpartum.Baseline and 12 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Nationwide Children's Hospital

🇺🇸

Columbus, Ohio, United States

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