ObesityPhase 2PEPNCT00164515
Increasing Physical Activity Among Overweight Women With Mobility Disabilities.
A Phase 2 study testing Personalized exercise programme (PEP) in people with Obesity, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
This study aims to increase physical activity among overweight African-American women with mobility limitations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Personalized exercise programme (PEP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- did not receive physician approval to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois, Chicago
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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).
- Conditions
- Obesity
- Being tested
- Personalized exercise programme (PEP)
- Keywords
- obesity, mobility limitations, women, physical activity
- Medical subject headings
- Obesity, Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized exercise programme (PEP)Behavioural
Also called PEP
Physician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Physical activity awareness | No intervention | The awareness group received a physician-recommendation to exercise an informational brochure, and pedometer. |
| Arm 2: Lower Support | Experimental | The lower support group received arm 1 plus monthly newsletter, weekly personalized exercise support via telephone. Receives: Behavioral: Personalized exercise programme (PEP) |
| Arm 3: Higher support | Experimental | The higher support group received arm 1 plus arm 2 plus a face-to-face monthly exercise support group. Receives: Behavioral: Personalized exercise programme (PEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
Body mass index (BMI)
Derived emperically
Measured: 24 months
Blood lipids
Derived emperically
Measured: 24 months
Weight
Derived emperically
Measured: 24 months
Blood Pressure
Dervied emperically
Measured: 24 months
Secondary outcomes (1)
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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of Illinois, Center on Health Promotion Research for Persons with Disabilities
- Responsible party
- Sponsor
- Investigators
- James Rimmer, Ph.D., Principal investigator, UIChicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164515
- Sponsor's protocol ID
- CDC-NCBDDD-R04CCR523275
- Other IDs
- R04CCR518810
- Acronym
- PEP
- Status last verified
- Jul 2019
- First submitted
- 12 Sep 2005
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19459233
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Exercise Programme (PEP) I: Physician Referral Approach to Increasing Awareness and Sustainability of Physical Activity for Overweight Adults With Mobility Limitations.
- ClinicalTrials.gov ID
- NCT00164515
- Acronym / sponsor ID
- PEP / CDC-NCBDDD-R04CCR523275
- Conditions
- Obesity
- Keywords
- obesity, mobility limitations, women, physical activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of Illinois, Center on Health Promotion Research for Persons with Disabilities
- Study start
- Oct 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Physical activity awareness | No intervention | –The awareness group received a physician-recommendation to exercise an informational brochure, and pedometer. |
| Arm 2: Lower Support | Experimental | Behavioral: Personalized exercise programme (PEP)The lower support group received arm 1 plus monthly newsletter, weekly personalized exercise support via telephone. |
| Arm 3: Higher support | Experimental | Behavioral: Personalized exercise programme (PEP)The higher support group received arm 1 plus arm 2 plus a face-to-face monthly exercise support group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- did not receive physician approval to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized exercise programme (PEP)Also: PEPPhysician referred overweight and obese clients to 24 month personalized exercise programme at the U. of Illinois, Chicago | Behavioural | Arm 2: Lower Support, Arm 3: Higher support |
Primary outcome
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).
Body mass index (BMI)
Time frame: 24 months
Derived emperically
Blood lipids
Time frame: 24 months
Derived emperically
Weight
Time frame: 24 months
Derived emperically
Blood Pressure
Time frame: 24 months
Dervied emperically
1 secondary outcome
Psychosocial Health
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Results publication: PubMed 19459233Rimmer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Rimmer, Ph.D. principal investigator
UIChicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalized exercise programme (PEP) in people with Obesity, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00164515, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.