Pilot Project of Health Promotion for People With Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970294
• Other study ID #: 10946
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: July 18, 2012
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: July 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Health Promotion Program
10 week health promotion program 3-4 times per week

Locations

Country	Name	City	State
United States	Patricia Kluding PhD	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Patricia Kluding, PhD

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kluding PM, Singh R, Goetz J, Rucker J, Bracciano S, Curry N. Feasibility and effectiveness of a pilot health promotion program for adults with type 2 diabetes: lessons learned. Diabetes Educ. 2010 Jul-Aug;36(4):595-602. doi: 10.1177/0145721710370718. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment, Retention, Adherence	% of enrolled subjects who completed the trial	10 weeks	Yes
Secondary	Aerobic Fitness	peak VO2 as measured with a graded maximal exercise test on a cycle ergometer	Baseline and at 10 weeks (change score)	Yes
Secondary	Glycemic Control	HbA1c measure	Baseline and at 10 weeks (change score)	Yes