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Completed

NCT Number: NCT00542698

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

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

Completed

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Berkshire Health System, Pittsfield, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Effect of Physical Activity on Type II Diabetes Mellitus

Behavioral

Reviewing participants and a role model's continuous glucose monitor graphs, discussing benefits of physical activity and setting physical activity goals.

Primary outcomes

  1. increased physical activity

    Time frame: 8 Weeks

Secondary outcomes

  1. BP, BMI, & HgA1c (a long term measure of blood glucose)

    Time frame: 8 Weeks

Sponsors and collaborators

Lead sponsor

National Institute of Nursing Research (NINR)

Nih

Registry information

Official study title

Changing Activity Behavior With Glucose Sensor Feedback

Important dates

Study start
2004
Study completion
2005
First posted
Oct 11, 2007
Registry last updated
Oct 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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