NCT07712900 Nutrition Counselling for Cardiometabolic Multimorbidity
| NCT ID | NCT07712900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bahir Dar University |
| Condition | Cardiometabolic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 308 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 308 participants in total. It began in 2026-04-13 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Cardiometabolic multimorbidity is rising globally and in Ethiopia, yet many patients still receive little or no structured dietary education in chronic care settings. Although nutrition counselling has been studied in single conditions such as diabetes or hypertension, no prior research has evaluated its effectiveness among patients with cardiometabolic multimorbidity. Because people living with multiple chronic diseases have more complex dietary needs and greater self-management challenges, evidence from single-disease groups cannot be assumed to apply to them. In Ethiopia, it remains unknown whether nutrition counselling can improve dietary adherence, clinical outcomes, or nutrition related quality of life in this population. Objective: To examine the effect of nutrition counselling on dietary adherence, clinical outcomes, and nutrition related quality of life among patients with cardiometabolic multimorbidity in South Wollo, Northeast Ethiopia. Methods: A two-arm, parallel, cluster randomized controlled trial across 14 hospitals, with seven hospitals assigned to the intervention arm and seven to the control arm will be conducted. Adult patients diagnosed with two chronic conditions (type 2 diabetes and hypertension) will be recruited using systematic random sampling, resulting in a total sample size of 308 participants. The intervention group will receive nutrition counselling guided by the COM-B Model and adapted from national and international dietary guidelines. Six individualized counselling sessions will be delivered over a period of three months. The control group will continue to receive routine care. Dietary adherence, clinical parametres, and nutrition related quality of life will be outcome variables. Generalized structural equation modeling will be used to analyze dietary adherence, while structural equation modeling will be applied for clinical parametres and nutrition related quality of life. Results will be presented as adjusted estimates with 95% confidence intervals. Expected outcomes: This study is expected to generate evidence showing whether nutrition counselling can improve dietary adherence, clinical outcomes, and nutrition related quality of life among patients with cardiometabolic multimorbidity. The intervention is anticipated to enhance patients' dietary practices, support better control of blood pressure and fasting blood glucose, and contribute to improved quality of life.
Eligibility Criteria
Inclusion Criteria: Adults aged 18 years or older. Diagnosed with both type 2 diabetes mellitus (T2DM) and hypertension. Receiving chronic care at one of the participating public hospitals. Exclusion Criteria: Pregnant women. Lactating women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07712900 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiometabolic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07712900 currently recruiting?
Yes, NCT07712900 is actively recruiting participants. Contact the research team at foziyamohammed2018@gmail.com for enrollment information.
Where is the NCT07712900 trial being conducted?
This trial is being conducted at Dessie, Ethiopia.
Who is sponsoring the NCT07712900 clinical trial?
NCT07712900 is sponsored by Bahir Dar University. The trial plans to enroll 308 participants.