Physical Activity and Health Outcomes

NCT01833507 | Completed Phase 2

• 1 other identifier: 13-000675
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obese

Keywords

increased activity; weight loss; obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• number of hospitalizations

  4 months

Study Arms (2)

self-exercise

ACTIVE COMPARATOR

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

usual care

PLACEBO COMPARATOR

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

Interventions

Self-Exercise BEHAVIORAL

Behavioral Goal Setting

self-exercise

Usual Care BEHAVIORAL

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.

usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Paul Y Takahashi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 17, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)