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 Locations

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
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.
Experimental: Group 1
Device: Fitbit activity tracker
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

Maxine Mendelson

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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