Diabetes MellitusNCT00132288
MY PALS: A Community-Based Physical Activity Support Program for Older Adults
A study testing Motivational support and PALS - Physical activity for lifetime success in people with Diabetes Mellitus and Aging, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diabetes Mellitus, Aging
- What is being tested?
- Motivational support and PALS - Physical activity for lifetime success
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment or mental illness precluding independent judgement
- Physician assessment that program is not appropriate, e.g., marked frailty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Aging
- Being tested
- Motivational support, PALS - Physical activity for lifetime success
- Keywords
- Aging, Frailty, Sedentary, Falls, Physical Activity
- Medical subject headings
- Diabetes Mellitus, Frailty, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational supportBehavioural
Also called Based on Stanford's Active Choices model.
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 successBehavioural
Referral by a primary care provider to a community based support program to enhance uptake or maintenance of physical activity by the participants.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (4)
Change in level of activity for those contacted by community support program
Measured: 6 months
Change in activity level for those having a peer counselor
Measured: 6 months
Change in Hemoglobin A1c levels
Measured: 1 year
Determinants of choice in favor of study participation
Measured: does not apply
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startMay 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- James LoGerfo, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132288
- Sponsor's protocol ID
- 04-4349-E/A01
- Status last verified
- Dec 2007
- First submitted
- 17 Aug 2005
- Last updated
- 19 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Linking Clinical Quality Improvement Programs for Older Diabetics to a Community Based Activity Support Center
- ClinicalTrials.gov ID
- NCT00132288
- Acronym / sponsor ID
- 04-4349-E/A01
- Conditions
- Diabetes Mellitus, Aging
- Keywords
- Aging, Frailty, Sedentary, Falls, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- May 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairment or mental illness precluding independent judgement
- Physician assessment that program is not appropriate, e.g., marked frailty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational supportAlso: Based on Stanford's Active Choices model.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. | Behavioural | – |
| PALS - Physical activity for lifetime successReferral by a primary care provider to a community based support program to enhance uptake or maintenance of physical activity by the participants. | Behavioural | – |
Primary outcome
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
4 secondary outcomes
Change in level of activity for those contacted by community support program
Time frame: 6 months
Change in activity level for those having a peer counselor
Time frame: 6 months
Change in Hemoglobin A1c levels
Time frame: 1 year
Determinants of choice in favor of study participation
Time frame: does not apply
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James LoGerfo, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational support and PALS - Physical activity for lifetime success in people with Diabetes Mellitus and Aging, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2007.