Physical Activity and Participation

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Usual education; Behavioral: Counseling

• Registration Number: NCT02268916
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Study Start: 2015-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Results First Submitted: 2021-12-03
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Results First Posted: 2022-09-19
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wait-listed	Usual education	Usual activity during the study. At the end of the study, will receive OT-led counseling
Intervention	Counseling	OT-led counseling based on home activity pattern

Primary Outcome Measures

Name	Time	Method
Physical Activity	6 months	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	6 months	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.

Trial Locations

Locations (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI; 🇺🇸 Ann Arbor, Michigan, United States