Pilot Project of Health Promotion for People With Diabetes

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Health Promotion Program

• Registration Number: NCT00970294
• Lead Sponsor: Patricia Kluding, PhD

Brief Summary

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

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2009-09-01
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Results First Submitted: 2012-05-29
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-18
• Last Update Submitted: 2012-07-18
• Results First Posted: 2012-08-21
• Last Update Posted: 2012-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health Promotion Program	Health Promotion Program	Supervised exercise, educational sessions, dietary counseling

Primary Outcome Measures

Name	Time	Method
Recruitment, Retention, Adherence	10 weeks	% of enrolled subjects who completed the trial

Secondary Outcome Measures

Name	Time	Method
Aerobic Fitness	Baseline and at 10 weeks (change score)	peak VO2 as measured with a graded maximal exercise test on a cycle ergometer
Glycemic Control	Baseline and at 10 weeks (change score)	HbA1c measure

Trial Locations

Locations (1)

Patricia Kluding PhD; 🇺🇸 Kansas City, Kansas, United States