Physical Activity and Participation

NCT ID: NCT02268916

Last Updated: 2022-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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 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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

OT-led counseling based on home activity pattern

Group Type EXPERIMENTAL

Counseling

Intervention Type BEHAVIORAL

OT led counseling

Wait-listed

Usual activity during the study. At the end of the study, will receive OT-led counseling

Group Type PLACEBO_COMPARATOR

Usual education

Intervention Type BEHAVIORAL

At the end of the study, will receive OT-led counseling

Interventions

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Counseling

OT led counseling

Intervention Type BEHAVIORAL

Usual education

At the end of the study, will receive OT-led counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pearl G. Lee, MD

Role: PRINCIPAL_INVESTIGATOR

VA Ann Arbor Healthcare System, Ann Arbor, MI

Locations

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VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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O1190-W

Identifier Type: -

Identifier Source: org_study_id

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