Physical Activity and Participation

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT02268916

Collaborator

(none)

103

Enrollment

Location

Arms

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Counseling Behavioral: Usual education	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Veterans With Diabetes Mellitus: Improving Physical Activity and Participation

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention OT-led counseling based on home activity pattern	Behavioral: Counseling OT led counseling
Placebo Comparator: Wait-listed Usual activity during the study. At the end of the study, will receive OT-led counseling	Behavioral: Usual education At the end of the study, will receive OT-led counseling

Arm

Intervention/Treatment

Experimental: Intervention

OT-led counseling based on home activity pattern

Behavioral: Counseling

OT led counseling

Placebo Comparator: Wait-listed

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

Behavioral: Usual education

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

Outcome Measures

Primary Outcome Measures

Physical activity [6 months]
Home physical activity measurement and survey questions
Social participation [6 months]
Survey questionnaires

Other Outcome Measures

Physical function [3 months and 6 months]
6 minute walk, gait speed, timed up and go

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan	United States	48105

Sponsors and Collaborators

VA Office of Research and Development

Investigators

Principal Investigator: Pearl G. Lee, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT02268916

Other Study ID Numbers:

O1190-W

First Posted:

Oct 20, 2014

Last Update Posted:

Aug 19, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by VA Office of Research and Development

diabetes

physical activity

participation

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 19, 2020