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Increasing Physical Activity Among Overweight Women With Mobility Disabilities. (PEP)

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Personalized exercise programme (PEP)
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, mobility limitations, women, physical activity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois, Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Arm 1: Physical activity awareness

Arm 2: Lower Support

Arm 3: Higher support

Arm Description

The awareness group received a physician-recommendation to exercise an informational brochure, and pedometer.

The lower support group received arm 1 plus monthly newsletter, weekly personalized exercise support via telephone.

The higher support group received arm 1 plus arm 2 plus a face-to-face monthly exercise support group.

Outcomes

Primary Outcome Measures

Physical activity
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).
Body mass index (BMI)
Derived emperically
Blood lipids
Derived emperically
Weight
Derived emperically
Blood Pressure
Dervied emperically

Secondary Outcome Measures

Psychosocial Health
Confirmed using the Quality of Wellbeing scale (Anderson et al 1989), and CARDIA-2 scale, an 11-item assessment (Allen et al 2001).

Full Information

First Posted
September 12, 2005
Last Updated
July 24, 2019
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Illinois, Center on Health Promotion Research for Persons with Disabilities
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1. Study Identification

Unique Protocol Identification Number
NCT00164515
Brief Title
Increasing Physical Activity Among Overweight Women With Mobility Disabilities.
Acronym
PEP
Official Title
Personalized Exercise Programme (PEP) I: Physician Referral Approach to Increasing Awareness and Sustainability of Physical Activity for Overweight Adults With Mobility Limitations.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Illinois, Center on Health Promotion Research for Persons with Disabilities

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to increase physical activity among overweight African-American women with mobility limitations.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, mobility limitations, women, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Physical activity awareness
Arm Type
No Intervention
Arm Description
The awareness group received a physician-recommendation to exercise an informational brochure, and pedometer.
Arm Title
Arm 2: Lower Support
Arm Type
Experimental
Arm Description
The lower support group received arm 1 plus monthly newsletter, weekly personalized exercise support via telephone.
Arm Title
Arm 3: Higher support
Arm Type
Experimental
Arm Description
The higher support group received arm 1 plus arm 2 plus a face-to-face monthly exercise support group.
Intervention Type
Behavioral
Intervention Name(s)
Personalized exercise programme (PEP)
Other Intervention Name(s)
PEP
Intervention Description
Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago
Primary Outcome Measure Information:
Title
Physical activity
Description
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).
Time Frame
24 months
Title
Body mass index (BMI)
Description
Derived emperically
Time Frame
24 months
Title
Blood lipids
Description
Derived emperically
Time Frame
24 months
Title
Weight
Description
Derived emperically
Time Frame
24 months
Title
Blood Pressure
Description
Dervied emperically
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Psychosocial Health
Description
Confirmed using the Quality of Wellbeing scale (Anderson et al 1989), and CARDIA-2 scale, an 11-item assessment (Allen et al 2001).
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Rimmer, Ph.D.
Organizational Affiliation
UIChicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois, Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19459233
Citation
Rimmer JH, Rauworth A, Wang E, Heckerling PS, Gerber BS. A randomized controlled trial to increase physical activity and reduce obesity in a predominantly African American group of women with mobility disabilities and severe obesity. Prev Med. 2009 May;48(5):473-9. doi: 10.1016/j.ypmed.2009.02.008.
Results Reference
result
Links:
URL
http://www.ncpad.org/videos/fact_sheet.php?sheet=415
Description
PEP Toolkit consists of a Yamax SW-200 pedometer and a custom Velcro strap that allows the user to attach it in a variety of locations on either the upper or lower limbs to record activity levels in an appropriate manner

Learn more about this trial

Increasing Physical Activity Among Overweight Women With Mobility Disabilities.

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