Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT02473926|
Recruitment Status : Active, not recruiting
First Posted : June 17, 2015
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Motor Activity Health Behavior Diabetes Mellitus, Type 2||Behavioral: Physical Activity Behavioral: Questionnaires||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes|
|Actual Study Start Date :||December 2015|
|Actual Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Physical Activity Program Intervention
The intervention seeks to increase physical activity and improve strength by addressing individual , behavioral, and social/environmental factors. Health promotion clinic staff will deliver counseling by phone on a bi-weekly basis - a clinic physician assistant will coordinate with the counselor during in-person clinic visits, teach participants to perform strengthening exercise, and assess for safety concerns associated with type 2 diabetes.
In addition to behavioral counseling targeting social cognitive theory constructs, counselors will assist participants in the intervention group to set specific goals for physical activity in a paper log and on an electronic FitBit activity tracking device.Health promotion clinic staff will encourage participants to advance goals towards meeting U.S. physical activity guidelines of 150 minutes/week of moderate intensity activity and 2-3 days/week of strength activities.
Behavioral: Physical Activity
Physical Activity Program Intervention
Usual Care Group
Participants in the usual care arm will receive three mailings (Intervention Questionnaires) during the intervention phase. Health promotion clinic staff will mail materials from the Center for Disease Control and Prevention website that address general health aging topics.
Participants in the usual care arm will receive three mailings during the intervention phase.
- Change from Baseline in Objective Physical Activity at 4 months [ Time Frame: Week 1; Week 14 ]ActiGraph accelerometer measures physical activity objectively as minutes/week of moderate intensity and vigorous intensity physical activity, respectively.
- Change from Baseline in Physical Function at 4 months [ Time Frame: Week 1; week 14 ]Measured via 400-meter rapid gait speed test
- Change from Baseline in Physical Function at 4 months [ Time Frame: Week 0, Week 14 ]Measured via the Short Physical Performance Battery (SPPB), which evaluates balance, usual walking speed, and repeated chair rise.
- Change from Baseline in Grip Strength at 4 months [ Time Frame: Week 2; Week 15 ]Hand grip strength as measured by dynamometer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473926
|United States, Colorado|
|University of Colorado Denver | Anschutz Medical Campus|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Amy Huebschmann, MD||University of Colorado, Denver|