- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00970294
Pilot Project of Health Promotion for People With Diabetes
July 18, 2012 updated by: Patricia Kluding, PhD
Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Patricia Kluding PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diabetes type II
- age 40-70
Exclusion Criteria:
- hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
- significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
- recent symptoms of chest discomfort
- currently smoking or significant pulmonary pathology
- serious musculoskeletal problems that would limit ability to exercise
- current active involvement in a regular exercise program (> 3 times per week)
- open wounds on the weight bearing surface of the feet
- not able to ambulate independently
- stroke or other central nervous system pathology
- stage 2 hypertension (resting blood pressure > 160 systolic or > 100 diastolic)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Health Promotion Program
Supervised exercise, educational sessions, dietary counseling
|
10 week health promotion program 3-4 times per week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment, Retention, Adherence
Time Frame: 10 weeks
|
% of enrolled subjects who completed the trial
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and at 10 weeks (change score)
|
Glycemic Control
Time Frame: Baseline and at 10 weeks (change score)
|
HbA1c measure
|
Baseline and at 10 weeks (change score)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Patricia Kluding, PhD, University Of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
September 1, 2009
First Submitted That Met QC Criteria
September 1, 2009
First Posted (Estimate)
September 2, 2009
Study Record Updates
Last Update Posted (Estimate)
August 21, 2012
Last Update Submitted That Met QC Criteria
July 18, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10946 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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