- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02516865
Practical Approaches to Exercise in Moms (PE Moms)
August 5, 2015 updated by: Maxine Mendelson
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reena Oza-Frank, PhD
- Phone Number: 614-355-6625
- Email: reena.oza-frank@nationwidechildrens.org
Study Contact Backup
- Name: Maxine Mendelson
- Phone Number: 614-355-6685
- Email: maxine.mendelson@nationwidechildrens.org
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43215
- Recruiting
- Nationwide Children's Hospital
-
Contact:
- Maxine Mendelson
- Phone Number: 614-355-6685
- Email: maxine.mendelson@nationwidechildrens.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 2
|
Tracks steps taken, floors climbed, and distance traveled.
Sleep quality is an additional measurement.
Worn during typical daily activities.
|
Experimental: Group 1
|
Tracks steps taken, floors climbed, and distance traveled.
Sleep quality is an additional measurement.
|
No Intervention: Group 3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in baseline body weight at 12-months postpartum.
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
April 1, 2017
Study Registration Dates
First Submitted
May 13, 2015
First Submitted That Met QC Criteria
August 5, 2015
First Posted (Estimate)
August 6, 2015
Study Record Updates
Last Update Posted (Estimate)
August 6, 2015
Last Update Submitted That Met QC Criteria
August 5, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB15-00117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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