Physical Activity and Health Outcomes (PAHO)

Mayo Clinic

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obese; Overweight

Treatments: Behavioral: Usual Care; Behavioral: Self-Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01833507

13-000675

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients will be over the age of 18
2. Have a BMI over 25.0 kg/m2.
3. Have a Minnesota Medical Tiering concerning medical complexity of 3-4.

Exclusion criteria

1. Patients will be excluded if they have clinically documented dementia.
2. Subjects will be community dwelling and patients living in skilled nursing facilities will be excluded.
3. Subjects residing within a correctional institution will be excluded.
4. Subject is a female patient who is currently pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups, including a placebo group

self-exercise

Active Comparator group

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.

Treatment:

Behavioral: Self-Exercise

usual care

Placebo Comparator group

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.

Treatment:

Behavioral: Usual Care