N/A
Completed N=11
Pilot Project of Health Promotion for People With Diabetes
Source: ClinicalTrials.gov NCT00970294 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Recruitment, Retention, Adherence — 55 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment, Retention, Adherence |
55 | — |
| SECONDARY Aerobic Fitness |
0.75 | — |
| SECONDARY Glycemic Control |
-0.5 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00970294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.