A Phase 4 interventional study of PRECEDE HPE model and CHPE in Type 2 Diabetes Mellitus and Cardiovascular Risk Factor, sponsored by Hospital Carlos III, Madrid. Completed at 1 site in Spain. Open to participants aged 31 Years and older. Per ClinicalTrials.gov, last updated 2011-03-16.
Sponsored by Hospital Carlos III, Madrid · Phase 4, Interventional, and Prevention
BACKGROUND: Individual health education is considered to be essential in the overall care of patients with type 2 diabetes (DM2), although there is some uncertainty regarding its metabolic control benefits. There have been very few randomized studies on the effects of individual education on normal care in DM2 patients with a control group, and none of these have assessed the long-term results. Therefore, this study aims to use this design to assess the effectiveness of the PRECEDE (Predisposing, Reinforcing, Enabling, Causes in Educational Diagnosis, and Evaluation) education model in the metabolic control and the reduction of cardiovascular risk factors, in patients with type 2 diabetes.
METHODS: An open community randomized clinical trial will be carried out in 8 urban community health centers in the Northeastern Madrid (Spain). Six hundred patients with DM2 will be randomized in two groups: PRECEDE or conventional model for health promotion education. The main outcome measures is glycated hemoglobin A1C, body mass index (BMI), blood pressure, lipids and control criteria during the 2-year follow-up period.
Assignment to the Health Promotion Education (HPE) will be random, three centers will use conventional HPE (the control group) and the remaining five will use PRECEDE-type HPE. Eligible patients are selected from a list of DM2 patients by each professional using random sampling, until the predetermined sample size is attained.
Conventional HPE is defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, and was complemented by the criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults for 2004-2007
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 600 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hospital Carlos III, Madrid is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation.
Behavioral: CHPE
Behavioral: PRECEDE HPE model
The model considers the influence of the following three factors on health-related behavior: * Predisposing: factors influencing the patient's motivation to undertake the behavior to be analyzed or encouraged. * Facilitators: factors influencing the level of easiness or difficulty the patient and his/her family have in undertaking a given behavior. * Reinforcing: factors arising after the patient has undertaken the behavior, and which reward or punish it.
The CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation.
HbA1c level
Time frame: Final (before 2 years follow-up)
Blood Pressure
Systolic and Diastolic Blood Pressure
Time frame: Final (before 2 years follow-up)
Low-density lipoprotein (LDL) cholesterol
Time frame: Final (before 2 years of follow-up)
Body Mass Index (BMI)
Time frame: Final (before 2 years of follow-up
This study is completed, as verified in Mar 2003. You cannot join it, but the record below documents what was studied.
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Hospital Carlos III, Madrid