MedTrace Logo

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

NCT03453970 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-07-29

No results posted yet for this study

Summary

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

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

Therapeutic Education Program

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • University of Malaga

    lead OTHER

Principal Investigators

  • Jorge Caro Bautista, PhD · University of Malaga

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2021-12-01
Completion
2021-12-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03453970 on ClinicalTrials.gov