Nutrition Counselling for Cardiometabolic Multimorbidity

July 13, 2026 updated by: Foziya Mohammed Hussien, Bahir Dar University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction Cardiometabolic multimorbidity (CMM), commonly involving T2DM and hypertension, represents the most prevalent and burdensome cluster of chronic diseases (1-3). These conditions are interrelated through shared lifestyle risk factors, and their co-occurrence significantly increases the risk of cardiovascular complications, disability, and premature mortality (4, 5). Nutrition plays a central role in the prevention and management of these conditions, yet dietary adherence among patients remains poor, contributing to uncontrolled blood glucose and blood pressure(6, 7). Nutrition counselling may improve patients' dietary behaviors by enhancing knowledge, self-management skills, and adherence to recommended diets(7); however, evidence on its effect among patients with multiple chronic conditions is limited.

In Ethiopia, national NCD guidelines do not provide specific dietary recommendations for patients with coexisting diabetes and hypertension, and nutrition counselling is poorly integrated into routine chronic care services (8-10). Patients are often managed mainly with medications, with limited structured dietary support, resulting in poor disease control and increased risk of complications, polypharmacy, and hospital utilization(9, 10). Generating context-specific evidence on the effect of nutrition counselling on clinical outcomes is therefore essential to strengthen nutrition care integration and inform guideline development.

Beyond clinical outcomes, patients with CMM frequently experience emotional distress, dietary limitations, and social challenges that negatively affect their well-being and functional capacity (11, 12). Nutrition-related quality of life (NQoL) is particularly compromised in this group due to the complexity of managing multiple dietary restrictions alongside heavy medication loads and symptom burden (13, 14). Structured nutrition counselling might have the potential to improve self-efficacy, psychosocial well-being, and patient satisfaction by addressing the multidimensional impact of diet on daily life. No study has evaluated the effect of nutrition counselling on NQoL among patients with CMM. Generating such evidence is vital to demonstrate the broader value of nutrition counselling, support its integration into Ethiopia's routine NCD services, and inform policies aimed at improving patient-centered outcomes.

Methods This study will be conducted in South Wollo Zone, Amhara Regional State, Northeast Ethiopia, involving all 14 public hospitals as study clusters.

A two-arm parallel cluster randomized controlled trial will be conducted to evaluate the effect of nutrition counselling on dietary adherence, clinical outcomes (blood pressure, fasting blood glucose (FBG), and low-density lipoprotein (LDL), and NQoL among patients with CMM. Fourteen public hospitals will be included, with seven randomly assigned to the intervention group and seven to the control group. A total of 308 adults with coexisting type 2 diabetes and hypertension will be recruited using systematic random sampling.

Participants in the intervention group will receive six individualized nutrition counselling sessions over three months, guided by the COM-B Model, while the control group will receive routine care. Intervention fidelity will be assessed using the five domains of the NIH Behavior Change Consortium framework. Data will be collected at baseline and post-intervention. Perceived dietary adherence will be assessed using a questionnaire adapted from the Perceived Dietary Adherence Questionnaire (PDAQ) and aligned with DASH diet principles. Clinical outcomes, including blood pressure, FBG, and LDL levels, will be measured using standardized national and laboratory procedures. Fasting venous blood samples will be collected and analyzed following established specimen handling and quality assurance protocols. Mixed-effects regression models will be used to evaluate intervention effects while accounting for clustering and relevant covariates.

Study Type

Interventional

Enrollment (Estimated)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary Adherence
Time Frame: From enrollment to the end of intervention at 3 months
Perceived dietary adherence will be assessed using 11 items questionnaire adapted from the Perceived Dietary Adherence Questionnaire (PDAQ) and tailored to align with the core principles of the Dietary Approaches to Stop Hypertension (DASH) diet. It includes 11 items covering consumption of fruits, vegetables, whole grains, high-fiber foods, low-glycemic index carbohydrates, fish and other omega-3 rich foods, healthy oils, sugary foods and drinks, high-fat or fried foods, salt intake, and overall adherence to dietary recommendations. Participants will be categorized as good adherence if they achieve a total score of 44 or higher (following recommended dietary practices on four or more days per week for all 11 items) and poor adherence if they score less than 44 (fewer than four days per week).
From enrollment to the end of intervention at 3 months
Fasting Blood Glucose
Time Frame: From enrollment to the end of intervention at 3 months
To test fasting blood glucose(FBG), a 5 ml venous blood sample will be drawn in the morning after overnight fasting for at least 8 hours. Laboratory's venipuncture and specimen handling SOPs will be followed during sample collection. Blood samples will be collected using sterile tubes and handled using standard infection prevention and control procedures. FBG will be analyzed using biochemistry analyzers, following the manufacturer's SOP and laboratory quality assurance guidelines. Calibration and internal quality control procedures will be performed daily. The FBG test will be conducted under the supervision of senior medical laboratory technologists to ensure accuracy and adherence to SOPs. Higher values indicate poorer glycemic control.
From enrollment to the end of intervention at 3 months
Blood pressure
Time Frame: From enrollment to the end of intervention at 3 months
Blood pressure will be measured in accordance with the Ethiopian National NCD protocol. Participants will be seated comfortably with their back supported and legs uncrossed, and will remain relaxed for at least five minutes prior to measurement. They will be instructed to remain silent during and between measurements. Two blood pressure readings will be taken using a calibrated digital sphygmomanometer, with measurements spaced at five-minute intervals. The average of the systolic and diastolic readings will be used for analysis. Higher readings indicate poorer blood pressure control.
From enrollment to the end of intervention at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition-related Quality of Life
Time Frame: From baseline to 2 weeks after completion of the 3-month intervention period.
NQoL will be assessed using a structured questionnaire developed based on the original NQoL instrument by Barr and Schumacher (2003) and adapted for relevance to CMM patients. The tool will evaluate patients' perceptions of how their dietary habits and nutrition-related experiences affected various dimensions of their daily lives over the past two weeks. The questionnaire is organized into six domains: Food Impact, Self-Image, Psychological Factors, Social and Interpersonal Factors, Physical Functioning and Role, and Self-Efficacy. Participants will be responded to each item using a five-point Likert scale. The total possible score will be ranging from 21 to 105. Subscale scores will also have computed for domain-specific interpretation. Higher total and domain-specific scores will reflect more positive perceptions of the impact of nutrition on physical, psychological, social, and functional well-being.
From baseline to 2 weeks after completion of the 3-month intervention period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahir Dar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 13, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5087/20256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet made a final decision regarding sharing de-identified individual participant data. Any future decision will be made in accordance with the approved ethics protocol, participant informed consent, institutional policies, and applicable data protection requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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