Development of Self-Regulation in Individuals With Type 2 Diabetes

Completed · Not applicable

Conditions studied: Type 2 Diabetes

In brief

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 adjust dietary intake and physical activity through the use of current dietary and physical activity guidelines to help regulate their BG, to an education and self-monitoring only intervention (SM), on blood glucose, self-efficacy, and diabetes self-management activities.

Key facts

Study ID

NCT00941447

Run by

The University of Tennessee, Knoxville

People needed

15

Starts

2009-04-01

Expected to finish

2011-02-01

Last updated by the study team

2018-04-05

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Tennessee, Healthy Eating and Activity Laboratory (HEAL) — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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