Physical Activity and Participation

NCT02268916 | Completed Results DMC

• 1 other identifier: O1190-W
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; physical activity; participation

Outcome Measures

Primary Outcomes (2)

• 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.

  6 months

• 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.

  6 months

Other Outcomes (3)

• Physical Function

  6 months

• Physical Function

  6 months

• Physical Function

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

OT-led counseling based on home activity pattern

Behavioral: Counseling

Wait-listed

PLACEBO COMPARATOR

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

Behavioral: Usual education

Interventions

Counseling BEHAVIORAL

OT led counseling

Intervention

Usual education BEHAVIORAL

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

Wait-listed

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Medically unstable
• Hospitalized within the last 6 months
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

The study participants are predominantly male and are all veterans, so the results would be difficult to be generalized to female and non-veterans. Physical activity is measured by a survey, which may have recall bias.

Results Point of Contact

• Title: Pearl Lee, MD
• Organization: VA Ann Arbor

Pearl.Lee2@va.gov

734-845-3182

Study Officials

• Pearl G. Lee, MD

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: June 1, 2015
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 19, 2022
• Results First Posted: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)