Physical Activity and Health Outcomes

Overweight Clinical Trial

— PAHO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833507
• Other study ID #: 13-000675
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 12, 2013
• Last updated: January 13, 2016
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obese
• Overweight

Intervention

Behavioral:
• Self-Exercise
Behavioral Goal Setting
• 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. Participants will subsequently be given entry into the active intervention at the 2-month check.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	weight loss	To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.	4 months	No
Secondary	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	No