Status:
COMPLETED
Development of Self-Regulation in Individuals With Type 2 Diabetes
Lead Sponsor:
The University of Tennessee, Knoxville
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Abbott Diabetes Care
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The purpose of this investigation is to conduct a 12-week study to compare the effects of a self-regulation intervention (SR), in which participants will self-monitor their blood glucose (BG) and adju...
Detailed Description
As our nation continues to battle overweight and obesity, the prevalence of diabetes will precipitously increase, placing additional financial burden on our country. Therefore, finding ways to manage ...
Eligibility Criteria
Inclusion
- Recruitment from Cherokee Health Systems, Healthy Eating and Activity Laboratory Ineligible Database, UTK faculty and staff, and local endocrinologists' offices.
- Have been diagnosed with Type 2 diabetes for a minimum of 1 year.
- Fasting BG of ≥ 126mg/dl6.
- Between the age of 21 and 65 years. Older adults may have more medical co-morbidities and may require greater medical supervision29.
- Considered overweight or obese by the body mass index (BMI). BMI between 27 and 45 kg/m2 29. The American Diabetes Association 2008 position statement for current nutrition recommendations and interventions for diabetes encourages those individuals within this BMI range to follow the low-calorie, low-fat diet that is prescribed in both conditions in this investigation6.
- Not treated with insulin.
- Are taking medicine that do not typically cause hypoglycemia: Refer to diabetes medication list in Appendices Ai-Aii.
- Willing to increase physical activity to 150mins/week in 3 months.
- Willing to be randomized to either condition.
- Able to report that they can read and understand English.
- Able to report that they can keep a food diary and perform basic mathematics.
Exclusion
- Report a heart condition, chest pain during periods of activity or rest or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals self-reporting joint problems, prescription medication usage related to heart conditions, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
- Report being unable to walk for 2 blocks (1/4 mile) without stopping.
- Report major psychiatric diseases.
- Are compliant with dietary and physical activity recommendations to achieve ideal body weight.
- Taking any weight loss medication.
- Pregnant, expecting to be pregnant and/or lactating.
- Have no working phone.
- Are unwilling to participate in phone calls that are a part of the condition that in which they have been randomized.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00941447
Start Date
April 1 2009
End Date
February 1 2011
Last Update
April 5 2018
Active Locations (1)
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1
University of Tennessee, Healthy Eating and Activity Laboratory (HEAL)
Knoxville, Tennessee, United States, 37996