Physical Activity and Health Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Relationship Between Physical Activity and Health Outcomes in Overweight and Obese Medically Complex Adults, a Randomized Trial

Conditions
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Overweight, Obese

Intervention / Treatment
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* Behavioral: Self-Exercise
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: self-exercise<br>Intervention will include a video(DVD) on exercise, and 2 self-help manuals on exercise and nutrition, in addition to a journal and pedometer. | Behavioral: Self-Exercise<br>* Behavioral Goal Setting<br>|
| Placebo Comparator: usual care<br>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. | Behavioral: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 
| weight loss | To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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increased activity, weight loss, obesity