MY PALS: A Community-Based Physical Activity Support Program for Older Adults

December 13, 2007 updated by: University of Washington

A Randomized Controlled Trial Linking Clinical Quality Improvement Programs for Older Diabetics to a Community Based Activity Support Center

This is a study of whether physical activity of older adults can be improved by linking primary care clinics serving older adults to a community-based program that provides motivational support, including peer counselors, for engaging in and maintaining moderate levels of physical activity.

Health care providers at the participating study sites routinely assess and track diabetic patients' physical activity. In addition to this routine care, study volunteers are referred to a support program that has been modelled on the Active Choices Program. Changes in volunteers' levels of activity are measured at 3, 6, and 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The MY PALS project will focus on developing an organized approach to increasing physical activity for clients who have already decided they are willing to increase activity or who might be having difficulty maintaining activity.

The MY PALS study will enroll consenting patients at clinics in Southeast Seattle-initially at two Puget Sound Neighborhood Health Center community clinics. These clinics have existing programs to provide better care for diabetic patients by encouraging and tracking physical activity, but the existing programs do not include community-based motivational supports.

Goals and objectives: The primary aim of My PALS is to determine the effectiveness of a support program to improve levels of physical activity in older diabetic patients in a diverse group of patients of clinics in SE Seattle. Secondary aims include: 1) identifying barriers to increased physical activity despite the offer or use of enhanced supports, and examining what those barriers imply for future study; and 2) estimating non-costs of the intervention.

The program consists of phone support, in-person counseling if the volunteer chooses, and access to a mentor if the volunteer chooses.

At initial contact, participants will complete a baseline questionnaire, including a the Seattle Rapid Assessment of Physical Activity (Seattle-RAPA). Participants desiring to meet in person with a peer counselor will discuss further plans for action and followup. In addition, participants who desire extra support will be offered the option of an ongoing peer mentor.

Participants will receive follow-up calls at the agreed upon intervals-usually no more than weekly, nor less than monthly for the first 3 months. At 3, 6 and 12 months, volunteers will again be asked to complete followup questionnaires. Copies of the plans and follow up activity scores will be sent to the volunteers' health care providers.

The primary outcome measure will be change in Seattle-RAPA score at 12 months in the intervention participants compared to the wait-listed control patients. The latter will be offered the intervention in Year 2.

Study Type

Interventional

Enrollment (Actual)

305

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Washington
  - Seattle, Washington, United States, 98118
    - Southeast Senior Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Adults age 65 years and older. Depending on number of volunteers, may also include younger adults.
English, Vietnamese, Tagalog, and Cambodian speakers.
If successful, program will extend to non-diabetics older than 64 years

Exclusion Criteria:

Cognitive impairment or mental illness precluding independent judgement
Physician assessment that program is not appropriate, e.g., marked frailty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in physical activity of those allocated to the intervention group compared to "wait-listed" controls as measured by the Seattle-Rapid Assessment of Physical Activity questionnaire Time Frame: 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in level of activity for those contacted by community support program Time Frame: 6 months	6 months
Change in activity level for those having a peer counselor Time Frame: 6 months	6 months
Change in Hemoglobin A1c levels Time Frame: 1 year	1 year
Determinants of choice in favor of study participation Time Frame: does not apply	does not apply

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator: James LoGerfo, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

August 17, 2005

First Submitted That Met QC Criteria