Nutrition Counselling for Cardiometabolic Multimorbidity

NCT07712900 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Cardiometabolic Diseases

Interventions

BEHAVIORAL

COM-B Model-Based Nutrition Counselling

The intervention is a theory-informed, individualized nutrition counselling program specifically designed for adults with cardiometabolic multimorbidity. The counselling is based on the Capability, Opportunity, Motivation-Behaviour (COM-B) model, which systematically identifies and addresses behavioral determinants of dietary adherence. Unlike routine nutrition advice provided during outpatient care, the intervention incorporates a structured counselling protocol that targets participants' psychological and physical capability, social and physical opportunity, and reflective and automatic motivation to support sustainable dietary behavior change. Counselling sessions are individualized according to each participant's nutritional needs, barriers to adherence, readiness for change, and clinical condition.

Sponsors & Collaborators

  • Bahir Dar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-13
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • Ethiopia

Study Locations

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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 NCT07712900 on ClinicalTrials.gov