- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164515
Increasing Physical Activity Among Overweight Women With Mobility Disabilities. (PEP)
July 24, 2019 updated by: Centers for Disease Control and Prevention
Personalized Exercise Programme (PEP) I: Physician Referral Approach to Increasing Awareness and Sustainability of Physical Activity for Overweight Adults With Mobility Limitations.
This study aims to increase physical activity among overweight African-American women with mobility limitations.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Regular, sustainable physical activity can have a dramatic effect on reducing obesity and other secondary conditions and increasing quality of life.
People with mobility limitations have a higher level of physical inactivity resulting from numerous personal and environmental barriers to physical activity participation.
This project will evaluate the feasibility of increasing physical activity among overweight individuals with mobility limitations through physician-referrals to a personalized exercise programme at the Chicago-based National Center on Physical Activity and Disability (NCPAD).
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 2
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
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois, Chicago
-
-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years or older
- English speaking
- Self-reported mobility limitation
- BMI greater than or equal to 27
- Receiving care at the University of Illinois, Chicago (UIC) Medical Center
- Sedentary
Exclusion Criteria:
- did not receive physician approval to participate
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Arm 1: Physical activity awareness
The awareness group received a physician-recommendation to exercise an informational brochure, and pedometer.
|
|
Experimental: Arm 2: Lower Support
The lower support group received arm 1 plus monthly newsletter, weekly personalized exercise support via telephone.
|
Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago
Other Names:
|
Experimental: Arm 3: Higher support
The higher support group received arm 1 plus arm 2 plus a face-to-face monthly exercise support group.
|
Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity
Time Frame: 24 months
|
Physical activity was assessed using the Physical Activity and Disability Scale (PADS), the Barriers to Physical Activity and Disbility Scale (B-PADS), (Rimmer et al 2000) and the Mobility Limitation score (Velozo et al 1999).
|
24 months
|
Body mass index (BMI)
Time Frame: 24 months
|
Derived emperically
|
24 months
|
Blood lipids
Time Frame: 24 months
|
Derived emperically
|
24 months
|
Weight
Time Frame: 24 months
|
Derived emperically
|
24 months
|
Blood Pressure
Time Frame: 24 months
|
Dervied emperically
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychosocial Health
Time Frame: 24 months
|
Confirmed using the Quality of Wellbeing scale (Anderson et al 1989), and CARDIA-2 scale, an 11-item assessment (Allen et al 2001).
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James Rimmer, Ph.D., UIChicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2004
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Actual)
July 26, 2019
Last Update Submitted That Met QC Criteria
July 24, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCBDDD-R04CCR523275
- R04CCR518810 (Other Grant/Funding Number: CDC/NCBDDD/DHDD)
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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