Clinical trial NCT00132288: MY PALS: A Community-Based Physical Activity Support Program for Older Adults
Official title: A Randomized Controlled Trial Linking Clinical Quality Improvement Programs for Older Diabetics to a Community Based Activity Support Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Aging
Keywords: Aging
Frailty
Sedentary
Falls
Physical Activity
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-08-19
Enrollment: 305
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 1 year
Secondary outcomes:
measure: Change in level of activity for those contacted by community support program
timeFrame: 6 months
measure: Change in activity level for those having a peer counselor
timeFrame: 6 months
measure: Change in Hemoglobin A1c levels
timeFrame: 1 year
measure: Determinants of choice in favor of study participation
timeFrame: does not apply
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Southeast Senior Center
state: Washington
Study officials:
affiliation: University of Washington
name: James LoGerfo, MD
role: PRINCIPAL_INVESTIGATOR
References: