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Physical Activity and Participation

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VA Office of Research and Development

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Behavioral: Usual education
Behavioral: Counseling

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02268916
O1190-W

Details and patient eligibility

About

The purpose of the study is to investigate if the investigators can improve physical activity and social participation level among Veterans with diabetes.

Full 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.

Enrollment

104 patients

Sex

All

Ages

60+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

104 participants in 2 patient groups, including a placebo group

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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