Physical Activity and Health Outcomes

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833507

Acronym

PAHO

Enrollment

130

Registered

2013-04-17

Start date

2013-04-30

Completion date

2015-04-30

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese, Overweight

Keywords

increased activity, weight loss, obesity

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.

Interventions

BEHAVIORALSelf-Exercise

Behavioral Goal Setting

BEHAVIORALUsual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026