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

NCT ID: NCT00542698

Last Updated: 2007-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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Type 2 Diabetes Mellitus Glucose Monitor graphs Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Effect of Physical Activity on Type II Diabetes Mellitus

Intervention Type BEHAVIORAL

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

Interventions

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Effect of Physical Activity on Type II Diabetes Mellitus

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 ΒΌ mile in 10 minutes
* Taking glucocoricoids
* Serious health problems, such as heart problems, found on examination.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role lead

Principal Investigators

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Nancy A Allen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Worcester Medical School

Locations

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Berkshire Health System

Pittsfield, Massachusetts, United States

Site Status

Baystate Health System

Springfield, Massachusetts, United States

Site Status

Countries

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United States

References

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Abstract -OR 27: Effect of Counseling with Continuous Glucose Monitoring on Physical Activity Behaviors June 2006, Oral Presentation for American Diabetes Association 66th Scientific Session, Washington D.C

Reference Type RESULT

Other Identifiers

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NIH: F31 NR008818-01A1

Identifier Type: -

Identifier Source: secondary_id

00004009

Identifier Type: -

Identifier Source: org_study_id