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Pilot Project of Health Promotion for People With Diabetes

NCT ID: NCT00970294

Last Updated: 2012-08-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.

Detailed Description

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Conditions

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Diabetes

Keywords

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diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Health Promotion Program

Supervised exercise, educational sessions, dietary counseling

Group Type EXPERIMENTAL

Health Promotion Program

Intervention Type BEHAVIORAL

10 week health promotion program 3-4 times per week

Interventions

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Health Promotion Program

10 week health promotion program 3-4 times per week

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. diabetes type II
2. age 40-70

Exclusion Criteria

1. hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
2. significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
3. recent symptoms of chest discomfort
4. currently smoking or significant pulmonary pathology
5. serious musculoskeletal problems that would limit ability to exercise
6. current active involvement in a regular exercise program (\> 3 times per week)
7. open wounds on the weight bearing surface of the feet
8. not able to ambulate independently
9. stroke or other central nervous system pathology
10. stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic)
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patricia Kluding, PhD

OTHER

Sponsor Role lead

Responsible Party

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Patricia Kluding, PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Patricia Kluding, PhD

Role: STUDY_DIRECTOR

University of Kansas Medical Center

Locations

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Patricia Kluding PhD

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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Kluding PM, Singh R, Goetz J, Rucker J, Bracciano S, Curry N. Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Diabetes Educ. 2010 Jul-Aug;36(4):595-602. doi: 10.1177/0145721710370718. Epub 2010 Jun 8.

Reference Type RESULT
PMID: 20530663 (View on PubMed)

Other Identifiers

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10946

Identifier Type: -

Identifier Source: org_study_id