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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132288
• Other study ID #: 04-4349-E/A01
• Status: Completed
• Phase: N/A
• First received: August 17, 2005
• Last updated: December 13, 2007
• Start date: May 2005
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aging
• Diabetes Mellitus

Intervention

Behavioral:
• Motivational support
Participants in the PALS program at SE Seattle Senior Center are assigned a volunteer phone buddy who uses motivational interviewing techniques during bi weekly or monthly phone calls to encourage the participant to become more physically active.
• PALS - Physical activity for lifetime success
Referral by a primary care provider to a community based support program to enhance uptake or maintenance of physical activity by the participants.

Locations

Country	Name	City	State
United States	Southeast Senior Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year	No
Secondary	Change in level of activity for those contacted by community support program		6 months	No
Secondary	Change in activity level for those having a peer counselor		6 months	No
Secondary	Change in Hemoglobin A1c levels		1 year	No
Secondary	Determinants of choice in favor of study participation		does not apply	No