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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00547027
Other study ID # PG 017294
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received October 17, 2007
Last updated March 4, 2015
Start date April 2006
Est. completion date July 2007

Study information

Verified date March 2015
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of a tailored, print-based physical activity intervention for patients diagnosed with type 2 diabetes.


Description:

Given the growing rates of type 2 diabetes and the documented benefits of physical activity in the treatment of this illness, further research is needed to examine methods of targeting this patient group to achieve improvements in physical activity behavior. The primary aim of this planning grant is to implement a pilot study examining the feasibility and efficacy of an individually-targeted, theoretically-based physical activity intervention for patients with type 2 diabetes. The physical activity intervention is compared to usual care, and the primary outcome is weekly physical activity at a one-month follow-up. These pilot data would demonstrate the feasibility of partnering with a community agency for participant recruitment and program implementation, as well as the potential efficacy of this intervention to promote physical activity in this high-risk population.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- adults diagnosed with type 2 diabetes

- current patients referred to diabetes center

Exclusion Criteria:

- medical contra-indication to moderate-intensity physical activity

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
print-based physical activity intervention
individually-based, print-based physical activity intervention
usual care
print-based materials of nutritional information

Locations

Country Name City State
United States Florida State University Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary weekly physical activity one month
Secondary physical activity stage of change one month
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