Pilot Project of Health Promotion for People With Diabetes

Study Overview
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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.

Official Title
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Feasibility and Effectiveness of a Health Promotion Program on Aerobic Fitness and Glycemic Control for Adults With Type 2 Diabetes

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Health Promotion Program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health Promotion Program<br>Supervised exercise, educational sessions, dietary counseling | Behavioral: Health Promotion Program<br>* 10 week health promotion program 3-4 times per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment, Retention, Adherence | % of enrolled subjects who completed the trial | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aerobic Fitness | peak VO2 as measured with a graded maximal exercise test on a cycle ergometer | Baseline and at 10 weeks (change score) | 
| Glycemic Control | HbA1c measure | Baseline and at 10 weeks (change score) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes