Nutrition Counselling for Cardiometabolic Multimorbidity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBahir Dar University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • COM-B Model-Based Nutrition Counselling

    Behavioral

    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.

Treatment groups

308 Participants
are divided into 2 treatment groups
Group A: COM-B Model-Based Nutrition CounsellingExperimental treatment 1 intervention
Group B: Routine Clinical CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Dietary Adherence

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).

Time frame
From enrollment to the end of intervention at 3 months
2

Fasting Blood Glucose

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.

Time frame
From enrollment to the end of intervention at 3 months
3

Blood pressure

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.

Time frame
From enrollment to the end of intervention at 3 months

Secondary outcomes

1

Nutrition-related Quality of Life

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.

Time frame
From baseline to 2 weeks after completion of the 3-month intervention period.

Other outcomes

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