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Search / Trial NCT06189417

Effect Of Health Extension Worker-Led Based Interventions on Improving Self-Management Behavior Among Diabetic Patients in Ethiopia

Launched by DEBRE BERHAN UNIVERSITY · Dec 19, 2023

Trial Information

Current as of October 01, 2025

Enrolling by invitation

Keywords

Health Extension Worker, Self Management Behavior, Club Based Intervention, People With Diabetes

ClinConnect Summary

This study in Ethiopia tests whether a club-based program led by Health Extension Workers can help adults with diabetes manage their condition better and improve blood sugar results. Villages are randomly assigned to either receive the HEW-led club program or continue with usual care. About 560 adults with diabetes (roughly 280 in each group) will take part over about six months. The intervention involves regular weekly meetings (about 50 minutes each) where participants learn about healthy eating, regular exercise, keeping a healthy weight, quitting smoking, monitoring blood sugar, limiting alcohol, reducing sitting time, and taking medicines, with counseling and help connecting to other health services. The control group does not get this specific program.

Eligible participants are adults aged 20 to 79 with diabetes who are not pregnant, do not have other diabetes-related health problems at the start, and plan to stay in the study area for the duration. Participants will complete self-care questionnaires and have blood sugar tests at set times: fasting blood sugar and HbA1c (a blood test that shows average blood sugar over several weeks) to gauge glycemic control, with self-management behavior measured at six months and blood sugar measures at three and six months. A key goal is to see if the program boosts self-management and improves blood sugar, along with how acceptable the program is to participants. The trial is currently enrolling by invitation and is not regulated by the FDA.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with diabetes who have provided informed consent
  • Patients with diabetes who do not have any other diabetes-related health complications at the start of the study
  • Patients with diabetes who are not pregnant
  • Patients with diabetes who have completed six months in the study
  • Patients with diabetes who have expressed their intention to remain within the study facility (health post) and community.
  • Exclusion Criteria:
  • Patients who decline to provide consent
  • Patients who, based on medical assessment by their physician, are deemed unable to participate in the intervention
  • Patients who choose not to continue with the intervention.

About Debre Berhan University

Debre Berhan University is a leading academic institution located in Ethiopia, committed to advancing health research and education. As a clinical trial sponsor, the university leverages its extensive resources and expertise to facilitate innovative research initiatives aimed at improving public health outcomes. With a focus on community engagement and collaboration, Debre Berhan University strives to address local and global health challenges through rigorous scientific inquiry and the promotion of evidence-based practices. The university's dedication to ethical research standards and its emphasis on capacity building position it as a vital contributor to the advancement of medical knowledge and healthcare solutions.

Locations

Debre Birhan, Amhara, Ethiopia

Patients applied

0 patients applied

Trial Officials

Akine E Abosetugn, MPH

Principal Investigator

Debre Berhan University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported