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Pilot Project of Health Promotion for People With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Patricia Kluding, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00970294
First received: September 1, 2009
Last updated: July 18, 2012
Last verified: July 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 University of Kansas:

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


Secondary Outcome Measures:
  • Aerobic Fitness [ Time Frame: Baseline and at 10 weeks (change score) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Study First Received: September 1, 2009
Results First Received: May 29, 2012
Last Updated: July 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
diabetes

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

ClinicalTrials.gov processed this record on November 25, 2014