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NCT Number: NCT01316367

Effectiveness of PRECEDE Model for Health Education on Changes and Level of Control in Patients With Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Risk Factor Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

31 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Carlos III, Madrid

Madrid, 28029, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Older than 30 years of age, with previously diagnosed DM2 (cardinal clinical, plus random blood glucose > 200 mg/dl or oral glucose of > 200 mg/dl at 2 h, twice, or plasma fasting glucose of > 126 mg/dl on two occasions or being diagnosed previously, received specific treatment for DM2)

Exclusion criteria

  • Gestational diabetes
  • Patients involved in clinical trials
  • Patients with life expectancy less than 1 year (according to clinical judgment)
  • Patients who refused to participate
  • Homebound patients Patients meeting criteria for inclusion and not meeting any exclusion criteria were invited to participate, and were included after accepting and signing an informed consent form.

Treatment and study plan

PRECEDE HPE model

Behavioral

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.

CHPE

Behavioral

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.

Primary outcomes

  1. HbA1c level

    Time frame: Final (before 2 years follow-up)

Secondary outcomes

  1. Blood Pressure

    Time frame: Final (before 2 years follow-up)

    Systolic and Diastolic Blood Pressure

  2. Low-density lipoprotein (LDL) cholesterol

    Time frame: Final (before 2 years of follow-up)

  3. Body Mass Index (BMI)

    Time frame: Final (before 2 years of follow-up

Sponsors and collaborators

Lead sponsor

Hospital Carlos III, Madrid

Other

Registry information

Official study title

Effectiveness of PRECEDE Model for Health Education on Cardiovascular Risk Reduction in Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Mar 16, 2011
Registry last updated
Mar 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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