Lifestyle Intervention for Adults With Diabetes

Study Overview
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Brief Summary
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Physical activity is the cornerstone of good diabetes management, and yet effective physical activity intervention is not available. The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this intervention among older adults with diabetes. In addition to physical activity, the investigators will also assess if the intervention will improve social participation.

Detailed Description
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To tailor to the needs of older adults, the investigators developed an innovative lifestyle modification intervention that incorporates rehabilitation approaches to improve the participation of physical activities (PA) among sedentary older adults with type 2 diabetes. The intervention is developed based on well-established health behavior theory (i.e., self-regulation) and the conceptual framework from the World Health Organization, with several innovations not previously investigated in this population. The intervention: is tailored based on individual's unique patterns of daily PA performed within his/her environment as opposed to the total amount of PA performed in a day or a recall of activities over some time period; uses an accelerometer-assisted, field-based method to address the individual's unique physical and social environment; is delivered by a trained occupational therapist in brief counseling sessions, which can be easily translated into real clinical settings; and addresses participation, a patient-centered outcome that is associated with quality of life but has received limited attention outside of rehabilitation research.

Official Title
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Lifestyle Intervention for Adults With Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 65 years or older Has Type 2 diabetes mellitus Sedentary (less than 150 minutes of exercise in week) English-speaking Community living (i.e., not a nursing home resident) Ambulatory with or without cane or walker Able to operate accelerometer Competent to provide informed consent Exclusion Criteria: Medically unstable Dementia diagnosis Currently taking any medications for memory impairment Currently participating in a physical activity program Heart attack within the past month Self-reported illness or condition that would impair the cooperation with the study team or the ability to complete the study

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>OT-led counseling based on home activity pattern | Behavioral: Counseling<br>* OT led counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity: accelerometer counts | Change in physical activity from baseline as measured by having participants wearing an accelerometer on their wrists for one week at home at baseline and then at the end of the study. | baseline, 18 weeks | 
| Change in physical activity: Community Healthy Activities Model Program for Seniors (CHAMPS) survey | Change in self reported physical activities (Kcal/week) from baseline as measured by participants answering CHAMPS survey questions at baseline and at the end of the study. | baseline, 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in social participation:validated questionnaires from the Patient-Reported Outcomes Measurement Information System (PROMIS) assessment center | Changes in two subdomains of participation - ability to participate and satisfaction with participation, will be assessed by participants answering surveys at the baseline and then at the end of the study. | baseline, 18 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity