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Completed

NCT Number: NCT03453970

Effectiveness of a Diabetes Education Program Based on Tailored Interventions (Edep-Ti Study)

GOALS:

PRIMARY:

1. Analyze the overall impact of the proposed diabetes education program on metabolic control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood pressure).

SECONDARY: 2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height). 3. Analyze the impact of the program on the quality of life related to health. 4. Check the effect on lifestyles: compliance levels of physical exercise and adherence to diet mediterranean.

DESIGN: Cluster randomized controlled trial

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Service of Andalucía

Málaga, Spain

About this study

The reference population will be patients with a diagnosis of diabetes mellitus in treatment with oral antidiabetics, excluding the insulinized patients. They will then be randomly assigned by cluster, to the intervention group (individual education) or control (usual care) in the context of each health center participating in the project. After randomization centers, all professionals who decide to cooperate receive a training process on methodology for measuring results (clinical and questionnaire variables), while assigned to the experimental intervention, will also receive training on how to carry out the program of diabetologic education proposed. The follow-up period for both groups is 18 months obtained as clinical determinations: glycosylated hemoglobin (metabolic control), blood pressure, lipid profile, smoking and BMI; and as results reported by the patient through questionnaires: quality of life related to health, level of physical activity performed or adherence to the Mediterranean diet.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Type II Diabetes Mellitus diagnosed <10 years and classified in a computerized clinical history with poor metabolic control (HbA1c> 7% or BMI > 27.5) and in treatment with oral antidiabetics.

Exclusion criteria

  • Diabetes Mellitus type 1
  • Insulinized patients.
  • Patients who have received some type of structured educational intervention in the last year according to the data obtained in their clinical history.
  • Patients with some type of sensory or mental disability.
  • Gestational diabetes.
  • Patients with age equal to or greater than 75 years of age or minors.
  • Patients with inability to travel to their Health Center.

Treatment and study plan

therapeutic education program

Behavioral

The total duration of the program will be 12 weeks with a maximum of 6 sessions of 30 minutes each. In the first session, through the EBADE questionnaire, the needs will be identified by grouping them by the 4 constructs of the theory of planned behavior (behavioral beliefs, subjective norm, behaviors of perceived control and behavioral intention). The interventions and the number of sessions will be adapted depending on the areas identified with barriers. These interventions will be applied in both face-to-face and telephone modalities, using the Nursing Intervention Classification and their respective activities. The interventions will be carried out by nurses who have previously received training on the proposed program. Follow-ups will be carried out every 15 days.

Primary outcomes

  1. Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months

    Time frame: 0,6,12 and18 months

    Determination of HbA1c measured as a percentage

  2. Lipidic profile: change from basal total cholesterol (TC) at 6 months, change from total basal cholesterol at 12 months and change from total basal cholesterol at 18 months.

    Time frame: 0,6,12 and18 months

    Determination of total cholesterol (TC) values measured in milligrams per deciliter (mg/dl).

  3. Lipidic profile: change from baseline LDL cholesterol (LDLc) at 6 months, change from baseline LDLc at 12 months and change from baseline LDL cholesterol at 18 months.

    Time frame: 0,6,12 and18 months

    Determination of LDLc measured in milligrams per deciliter (mg/dl).

  4. Lipidic profile:change from basal triglyceride (TG) levels at 6 months, change from basal TG levels at 12 months and change from baseline TG levels at 18 months.

    Time frame: 0,6,12 and18 months

    Determination of TG measured in milligrams per deciliter (mg/dl).

  5. Change from baseline systolic blood pressure (SBP) at 6 months, change from baseline systolic blood pressure at 12 months and change from baseline systolic blood pressure at 18 months.

    Time frame: 0,6,12 and18 months

    Determination of systolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.

  6. Change from baseline diastolic blood pressure (DBP) at 6 months, change from baseline diastolic blood pressure at 12 months and change from baseline diastolic blood pressure at 18 months.

    Time frame: 0,6,12 and18 months

    Determination of diastolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.

Secondary outcomes

  1. Development in smoking habits

    Time frame: 0,6,12 and18 months

    Number of cigarettes consumed per day on average (measured at 0,6,12 and 18 months)

  2. Smoking rate

    Time frame: 0,6,12 and18 months

    Percentage of smokers of the total of the participants (measured at 0,6,12 and 18 months).

  3. Change from baseline weight at 6 months, change from baseline weight at 12 months and change from baseline weight at 18 months.

    Time frame: 0,6,12 and18 months

    Determination of the body mass index calculated as the weight measured in kilograms (kg) divided by the height measured in meters squared (weight / height2) (Kg /m2) (measured at 0,6,12 and 18 months).

  4. Change in the quality of life related to health (HRQoL) from the baseline determination at 6 months, change in the HRQoL from the baseline determination at 12 months and change in the HRQoL from the baseline determination at 18 months.

    Time frame: 0,6,12 and18 months

    The Diabetes Quality of Life Questionnaire EuroQol-5D (EQ-5D) in a Spanish version will be implemented at 0, 6, 12 and 18 months. With this questionnaire the individual himself assesses his health status, first in levels of severity (1-without problems, 2-some problems or moderate problems and 3-serious problems) by health dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety / depression). The combination of the values of all dimensions generates 5-digit numbers, with 243 combinations of possible health states. A second part of the questionnaire includes a vertical analog visual scale ranging from 0 (worst imaginable health status) to 100 (best imaginable health status). In it, the individual must mark the point in the vertical line that best reflects his or her subjective assessment of their overall health status.

  5. Change from the basal level of physical activity to 6 months, change from the basal level of physical activity to 12 months and change from the basal level of physical activity to 18 months.

    Time frame: 0,6,12 and18 months

    The International Physical Activity Questionnaire (IPAQ short version) will be implemented at 0, 6, 12 and 18 months. The IPAQ questionnaire in its short version is self-administered and consists of 7 questions that provide information on the time spent doing physical activities of moderate and vigorous intensity, separating time spent walking and time spent in a more passive state. Individuals can be classified into: low level of activity, moderate level (there are 3 criteria to classify a person as active) and high level of activity (there are 2 criteria to classify a person as very active).

  6. Change from the baseline level of adherence to the diet at 6 months, change from the baseline level of adherence to the diet at 12 months and change from the baseline level of adherence to the diet at 18 months.

    Time frame: 0,6,12 and18 months

    The Questionnaire of Adherence to the Mediterranean Diet will be implemented at 0, 6, 12 and 18 months. It is a self-administered questionnaire consisting of 14 segments dedicated to eating habits. To estimate the results, the value 1 is assigned to each segment with an affirmative response and 0 to each segment with a non compliant response. From the sum of the values obtained, the degree of adherence is determined, establishing two levels, so that if the total score is greater than or equal to 9 it is considered a diet with a good level of adherence and if the total sum is lower of 9 the diet is considered to be of a low adherence.

Other outcomes

  1. Change from the initial assessment of barriers to self-care at 6 months, change from the initial assessment of barriers to self-care at 12 months and change from the initial assessment of barriers to self-care at 18 months

    Time frame: 0,6,12 and18 months

    The questionnaire of evaluation of self-care barriers in diabetes (EBADE questionnaire) will be implemented at 0, 6, 12 and 18 months. This questionnaire consists of 15 items and 4 structured dimensions according to the Theory of Planned Behavior (behavioral beliefs, subjective norm, behavior of perceived control and behavioral intention), with a minimum score of 15 and a maximum of 105, higher score means better level of self-care behavior. The segments include questions related to diet, physical activity, medication, foot care, control of complications and accessibility to the health system.

  2. Participation in the program

    Time frame: 18 months

    Number of sessions attended

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

Effectiveness of a Diabetes Education Program Based on Tailored Interventions in the Andalusian Public Health and Social System (Edep-Ti Study).

Acronym: Edep-Ti

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2018
Registry last updated
Jul 29, 2025

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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