Physical Activity and Health Outcomes (PAHO)
Primary Purpose
Overweight, Obese
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-Exercise
Usual Care
Sponsored by

About this trial
This is an interventional treatment trial for Overweight focused on measuring increased activity, weight loss, obesity
Eligibility Criteria
Inclusion Criteria:
- Patients will be over the age of 18
- Have a BMI over 25.0 kg/m2.
- Have a Minnesota Medical Tiering concerning medical complexity of 3-4.
Exclusion Criteria:
- Patients will be excluded if they have clinically documented dementia.
- Subjects will be community dwelling and patients living in skilled nursing facilities will be excluded.
- Subjects residing within a correctional institution will be excluded.
- Subject is a female patient who is currently pregnant.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
self-exercise
usual care
Arm Description
Intervention will include a video(DVD) on exercise, and 2 self-help manuals on exercise and nutrition, in addition to a journal and pedometer.
Participants will have full access to all of the educational materials which are available to all Mayo Clinic patients in literature racks in the individual clinics.
Outcomes
Primary Outcome Measures
Gait, Grip and Walking
Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.
weight loss
To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.
Secondary Outcome Measures
number of hospitalizations
Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01833507
Brief Title
Physical Activity and Health Outcomes
Acronym
PAHO
Official Title
Relationship Between Physical Activity and Health Outcomes in Overweight and Obese Medically Complex Adults, a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity is common in adults with complex medical problems with ensuing complications afterwards. Obese patients suffer higher mortality and impaired functional status often as a result of their obesity. One primary goal to reduce both obesity and improve functional status is exercise. The investigators hypothesize that a simple exercise intervention with limited behavioral goal-setting will reduce weight and increase functional status compared to usual care. As a secondary measure, the investigators hypothesize that using this intervention will reduce hospital admissions and ER visits.
Detailed Description
We are enrolling up to 150 subjects where half will receive a pedometer and behavioral goal-setting at enrollment and half will receive a pedometer and goal-setting 2 months later. It is a 4 month study. Our aims are as follows:
Primary Aim: Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.
Second Primary aim: To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.
Secondary Aim: Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
increased activity, weight loss, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
self-exercise
Arm Type
Active Comparator
Arm Description
Intervention will include a video(DVD) on exercise, and 2 self-help manuals on exercise and nutrition, in addition to a journal and pedometer.
Arm Title
usual care
Arm Type
Placebo Comparator
Arm Description
Participants will have full access to all of the educational materials which are available to all Mayo Clinic patients in literature racks in the individual clinics.
Intervention Type
Behavioral
Intervention Name(s)
Self-Exercise
Intervention Description
Behavioral Goal Setting
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will have full access to all of the educational materials which are available to all Mayo Clinic patients in literature racks in the individual clinics. Participants will subsequently be given entry into the active intervention at the 2-month check.
Primary Outcome Measure Information:
Title
Gait, Grip and Walking
Description
Determine the relationship between gait speed, grip strength and walking steps in patients randomized to a self-exercise program compared to usual care in complex medical patients.
Time Frame
4 months
Title
weight loss
Description
To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
number of hospitalizations
Description
Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients will be over the age of 18
Have a BMI over 25.0 kg/m2.
Have a Minnesota Medical Tiering concerning medical complexity of 3-4.
Exclusion Criteria:
Patients will be excluded if they have clinically documented dementia.
Subjects will be community dwelling and patients living in skilled nursing facilities will be excluded.
Subjects residing within a correctional institution will be excluded.
Subject is a female patient who is currently pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Y Takahashi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Physical Activity and Health Outcomes
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