Back to resultsPractical Approaches to Exercise in Moms (PE Moms)
Primary Purpose
Body Weight
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fitbit activity tracker
Ankle weights
Sponsored by
About this trial
This is an interventional prevention trial for Body Weight focused on measuring postpartum, physical activity
Eligibility Criteria
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
Sites / Locations
- Nationwide Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Group 1
Group 2
Group 3
Arm Description
Outcomes
Primary Outcome Measures
Change in baseline body weight at 12-months postpartum.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02516865
Brief Title
Practical Approaches to Exercise in Moms
Acronym
PE Moms
Official Title
Practical Approaches to Exercise in Moms
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maxine Mendelson
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight
Keywords
postpartum, physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Title
Group 2
Arm Type
Experimental
Arm Title
Group 3
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Fitbit activity tracker
Intervention Description
Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.
Intervention Type
Device
Intervention Name(s)
Ankle weights
Intervention Description
Worn during typical daily activities.
Primary Outcome Measure Information:
Title
Change in baseline body weight at 12-months postpartum.
Time Frame
Baseline and 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reena Oza-Frank, PhD
Phone
614-355-6625
Email
reena.oza-frank@nationwidechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maxine Mendelson
Phone
614-355-6685
Email
maxine.mendelson@nationwidechildrens.org
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxine Mendelson
Phone
614-355-6685
Email
maxine.mendelson@nationwidechildrens.org
12. IPD Sharing Statement
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Practical Approaches to Exercise in Moms
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