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OpenTrials
Completed

NCT Number: NCT01833507

Physical Activity and Health Outcomes

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.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-Exercise

Behavioral

Behavioral Goal Setting

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.

Primary outcomes

  1. Gait, Grip and Walking

    Time frame: 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.

  2. weight loss

    Time frame: 4 months

    To determine the effect of a self-exercise program compared to usual care on weight loss in complex medical patients.

Secondary outcomes

  1. number of hospitalizations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: PAHO

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2013
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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