Physical Activity and Health Outcomes

Phase 2

Completed

• Conditions: Obese; Overweight
• Interventions: Behavioral: Usual Care; Behavioral: Self-Exercise

• Registration Number: NCT01833507
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-17
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	Usual Care	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.
self-exercise	Self-Exercise	Intervention will include a video(DVD) on exercise, and 2 self-help manuals on exercise and nutrition, in addition to a journal and pedometer.

Primary Outcome Measures

Name	Time	Method
Gait, Grip and Walking	4 months	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	4 months	To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.

Secondary Outcome Measures

Name	Time	Method
number of hospitalizations	4 months	Determine the relationship between the number of hospitalizations in patients randomized to a self-exercise program compared to usual care in complex medical patients.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States