Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
NCT ID: NCT02473926
Last Updated: 2023-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2015-12-31
2019-07-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Questionnaires
Participants in the usual care arm will receive three mailings during the intervention phase.
Interventions
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Physical Activity
Physical Activity Program Intervention
Questionnaires
Participants in the usual care arm will receive three mailings during the intervention phase.
Eligibility Criteria
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Inclusion Criteria
* Sedentary individual, performing \<20 minutes of physical activity on \<3 days/week
Exclusion Criteria
* Excessive fall risk: Can not hold semi-tandem stance for \>10 seconds
* Type 2 diabetes-related safety concerns: Prior diabetic foot ulcer, Charcot foot, asymptomatic hypoglycemia
* Severely uncontrolled hypertension (BP \>180/100)
* Excessive hearing or visual impairment for counseling
* Limited life expectancy: Active treatment for malignancy
* Performs regular physical activity \>20 minutes on \>3 days/week
50 Years
85 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Amy Huebschmann, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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References
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Huebschmann AG, Glasgow RE, Leavitt IM, Chapman K, Rice JD, Lockhart S, Stevens-Lapsley JE, Reusch JEB, Dunn AL, Regensteiner JG. Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial. Transl Behav Med. 2022 May 25;12(4):601-610. doi: 10.1093/tbm/ibac014.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-1080
Identifier Type: -
Identifier Source: org_study_id
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