Physical Activity and Participation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.

Detailed Description
-----------------
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 Veterans with diabetes in a randomized-controlled trial. In addition to physical activity, the investigators will also assess if the intervention will improve social participation among Veterans.

Official Title
-----------------
Veterans With Diabetes Mellitus: Improving Physical Activity and Participation

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Counseling
* Behavioral: Usual education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans Aged 60 years or older Has Type 2 diabetes mellitus Able to operate accelerometer Competent to consent to the study No dementia diagnosis Ambulatory with or without assistive device English-speaking Community living (i.e., not a nursing home resident) Not physically active on a regular basis (less than 150 minutes of moderate or vigorous physical activity per week) Exclusion Criteria: Medically unstable Hospitalized within the last 6 months 2 or more days of complete bed rest in the last month hemiplegia or limb amputation Self-reported illness or conditions that would impair the cooperation with the study team or the ability to complete the study work involved in shift schedule current enrollment of a physical activity program replacement of hip or knee within the last 6 months. Parkinson's disease frequent falls

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


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>|
| Placebo Comparator: Wait-listed<br>Usual activity during the study. At the end of the study, will receive OT-led counseling | Behavioral: Usual education<br>* At the end of the study, will receive OT-led counseling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Home physical activity changes from baseline to 6-months.Physical activity was measured using a validated survey called CHAMPS, asking the participants to report activities that they participated in a typical week, such as walking, doing house work, dancing, etc. | 6 months | 
| Social Participation | Survey questionnaires of participation change from baseline to 6-months follow up, specifically, satisfaction with participation in social roles, satisfaction with participation in discretionary social activities, and ability to participate in social roles and activities. Each survey has been validated and scored on the T-score metrics. A T-score is a standardized score, and has a middle score; it is 50 for T-scores. This middle score is the mean of a large sample that is representative of the US general population. The survey results are T-score metrics in which 50 is the mean score of the general population and 10 is the standard deviation (SD) of that population. The study outcomes are changes in T-scores of each survey from baseline to 6-months follow-up, where positive score means improved outcome, and negative score means worse outcome at 6-months. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, physical activity, participation