Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Practical Approaches to Exercise in Moms (PE Moms)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02516865
Recruitment Status : Unknown
Verified August 2015 by Maxine Mendelson, Nationwide Children's Hospital.
Recruitment status was:  Recruiting
First Posted : August 6, 2015
Last Update Posted : August 6, 2015
Sponsor:
Information provided by (Responsible Party):
Maxine Mendelson, Nationwide Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Body Weight Device: Fitbit activity tracker Device: Ankle weights Phase 1

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Practical Approaches to Exercise in Moms
Study Start Date : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 Device: Fitbit activity tracker
Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.

Experimental: Group 2 Device: Fitbit activity tracker
Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.

Device: Ankle weights
Worn during typical daily activities.

No Intervention: Group 3



Primary Outcome Measures :
  1. Change in baseline body weight at 12-months postpartum. [ Time Frame: Baseline and 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516865


Contacts
Layout table for location contacts
Contact: Reena Oza-Frank, PhD 614-355-6625 reena.oza-frank@nationwidechildrens.org
Contact: Maxine Mendelson 614-355-6685 maxine.mendelson@nationwidechildrens.org

Locations
Layout table for location information
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43215
Contact: Maxine Mendelson    614-355-6685    maxine.mendelson@nationwidechildrens.org   
Sponsors and Collaborators
Maxine Mendelson
Layout table for additonal information
Responsible Party: Maxine Mendelson, Clinical Research Coordinator, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02516865    
Other Study ID Numbers: IRB15-00117
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: August 6, 2015
Last Verified: August 2015
Keywords provided by Maxine Mendelson, Nationwide Children's Hospital:
postpartum
physical activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight