Back to resultsPhysical Activity and Participation
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Usual education
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, physical activity, participation
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
Sites / Locations
- VA Ann Arbor Healthcare System, Ann Arbor, MI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Wait-listed
Arm Description
OT-led counseling based on home activity pattern
Usual activity during the study. At the end of the study, will receive OT-led counseling
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02268916
First Posted
October 15, 2014
Last Updated
September 8, 2022
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02268916
Brief Title
Physical Activity and Participation
Official Title
Veterans With Diabetes Mellitus: Improving Physical Activity and Participation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, physical activity, participation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
OT-led counseling based on home activity pattern
Arm Title
Wait-listed
Arm Type
Placebo Comparator
Arm Description
Usual activity during the study. At the end of the study, will receive OT-led counseling
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
OT led counseling
Intervention Type
Behavioral
Intervention Name(s)
Usual education
Intervention Description
At the end of the study, will receive OT-led counseling
Primary Outcome Measure Information:
Title
Physical Activity
Description
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.
Time Frame
6 months
Title
Social Participation
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Physical Function
Description
Six month changes in timed up and go test, where the participant get up from sitting in a chair, walk meters, turn around, and walk back to sit down. Positive changes means worse outcome for timed up and go (seconds).
Time Frame
6 months
Title
Physical Function
Description
Six month changes in gait speed, which is the comfortable gait peed in 10 meter walking. Positive changes means better outcomes for gait speed (meters per second).
Time Frame
6 months
Title
Physical Function
Description
Six month changes in six-minute walk test, which measures the distance a participant walked at usual pace for six minutes. Positive changes means better outcomes for six-minute walk (meters).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pearl G. Lee, MD
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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