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NCT02516865 Clinical Trial

Practical Approaches to Exercise in Moms

Body Weight Clinical Trial

— PE Moms  

Official title:
Practical Approaches to Exercise in Moms

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02516865
Other study ID # IRB15-00117
Secondary ID
Status Recruiting
Phase Phase 1
First received May 13, 2015
Last updated August 5, 2015
Start date April 2015
Est. completion date April 2017

Study information
Verified date August 2015
Source Nationwide Children's Hospital
Contact Reena Oza-Frank, PhD
Phone 614-355-6625
Email reena.oza-frank@nationwidechildrens.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 30
Est. completion date April 2017
Est. primary completion date April 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Fitbit activity tracker
Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.
• Ankle weights
Worn during typical daily activities.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Maxine Mendelson

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in baseline body weight at 12-months postpartum. Baseline and 12 months No
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