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Pilot Project of Health Promotion for People With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970294
First Posted: September 2, 2009
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patricia Kluding, PhD, University of Kansas Medical Center Research Institute
  Purpose
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.

Condition Intervention
Diabetes Behavioral: Health Promotion Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Patricia Kluding, PhD, University of Kansas Medical Center Research Institute:

Primary Outcome Measures:
  • Recruitment, Retention, Adherence [ Time Frame: 10 weeks ]
    % of enrolled subjects who completed the trial


Secondary Outcome Measures:
  • Aerobic Fitness [ Time Frame: Baseline and at 10 weeks (change score) ]
    peak VO2 as measured with a graded maximal exercise test on a cycle ergometer

  • Glycemic Control [ Time Frame: Baseline and at 10 weeks (change score) ]
    HbA1c measure


Enrollment: 11
Study Start Date: July 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Health Promotion Program
Supervised exercise, educational sessions, dietary counseling
Behavioral: Health Promotion Program
10 week health promotion program 3-4 times per week

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970294


Locations
United States, Kansas
Patricia Kluding PhD
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Patricia Kluding, PhD
Investigators
Study Director: Patricia Kluding, PhD University of Kansas Medical Center
  More Information

Publications:
Responsible Party: Patricia Kluding, PhD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00970294     History of Changes
Other Study ID Numbers: 10946
First Submitted: September 1, 2009
First Posted: September 2, 2009
Results First Submitted: May 29, 2012
Results First Posted: August 21, 2012
Last Update Posted: August 21, 2012
Last Verified: July 2012

Keywords provided by Patricia Kluding, PhD, University of Kansas Medical Center Research Institute:
diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases