Changing Physical Activity Behavior in Individuals With Type 2 Diabetes Using Counceling and Information From Continuous Glucose Monitoring

National Institutes of Health (NIH)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Effect of Physical Activity on Type II Diabetes Mellitus

Study type: Interventional

Funder types: NIH

Identifiers

NCT00542698

00004009

NIH: F31 NR008818-01A1

Details and patient eligibility

About

The purpose of this study was to develop a nurse counseling intervention to increase physical activity behavior in people with type 2 diabetes and to improve their health

Full description

Diabetes affects 20.8 million Americans and is the fifth leading cause of death in the United States. Although physical activity is a cornerstone in the treatment of diabetes, it is difficult to change physical activity behaviors and up to 60% of individuals with diabetes do not participate in regular physical activity. The use of a nurse counseling intervention based on established behavior change theory with technology-derived graphical representations of glucose information created a unique opportunity to test the feasibility of motivating people with type 2 diabetes to change physical activity behaviors. The consent form described the study protocol, participant expectations, benefits, risks, and the process of maintaining participant confidentiality.

Enrollment: 52 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of Type 2 Diabetes Mellitus
• Three month blood sugar test (HbA1c) > 7.5%
• Not receiving insulin to manage diabetes
• Not engaged in a physical activity program more than 2 days per week
• Able to read and speak English

Exclusion criteria

• Not able to walk ¼ mile in 10 minutes
• Taking glucocoricoids
• Serious health problems, such as heart problems, found on examination.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Control

No Intervention group

Description:

Control group uses 90 minutes of standard diabetes education/ 7 days using the International Diabetes Center curriculum \& update phone call at 4 weeks.

Intervention

Experimental group

Description:

Interventional group received standard diabetes education, CGMS monitor, and extra educational topics including CGMS counceling.

Treatment:

Behavioral: Effect of Physical Activity on Type II Diabetes Mellitus