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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Ethiopia
Dessie Comprehensive Specialized Hospital
RECRUITING
Dessie
Contact Information
Primary
Foziya Hussien
foziyamohammed2018@gmail.com
251913714985
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2026-08
Participants
Target number of participants: 308
Treatments
Experimental: COM-B Model-Based Nutrition Counselling
Participants allocated to the COM-B Model-Based Nutrition Counselling arm will receive a structured, individualized nutrition counselling program in addition to routine clinical care. The counselling is based on the Capability, Opportunity, Motivation-Behaviour (COM-B) model and is designed to improve dietary adherence among patients with cardiometabolic multimorbidity. The intervention will be delivered by trained healthcare professionals using a standardized counselling manual to ensure consistency across study sites. Counselling sessions will focus on healthy dietary practices for the management of cardiometabolic multimorbidity. Participants will also receive individualized dietary advice tailored to their clinical condition, nutritional needs, food preferences, socioeconomic circumstances, and locally available foods. Behavior change techniques will be incorporated into the counselling.
No_intervention: Routine Clinical Care
Participants allocated to the routine clinical care arm will receive routine clinical care provided by the participating health facilities for the management of cardiometabolic multimorbidity. Participants in the routine clinical care arm will not receive the structured COM-B model-based nutrition counselling program, standardized counselling manual, individualized behavior change strategies, or additional nutrition education materials provided to the intervention group.
Related Therapeutic Areas
Sponsors
Leads: Bahir Dar University

This content was sourced from clinicaltrials.gov