Nutrition Counselling for Cardiometabolic Multimorbidity

NCT07712900 | Recruiting DMC

• 1 other identifier: 5087/20256
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Diseases

Keywords

Cardiometabolic Multimorbidity; Cardiometabolic Comorbidity; Nutrition Counselling; Dietary Adherence; Nutrition-related Quality of Life

Outcome Measures

Primary Outcomes (3)

• 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).

  From enrollment to the end of intervention at 3 months

• 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.

  From enrollment to the end of intervention at 3 months

• 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.

  From enrollment to the end of intervention at 3 months

Secondary Outcomes (1)

• Nutrition-related Quality of Life

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

Study Arms (2)

COM-B Model-Based Nutrition Counselling

EXPERIMENTAL

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

Routine Clinical Care

NO INTERVENTION

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.

Interventions

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.

COM-B Model-Based Nutrition Counselling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women. Lactating women.

Sponsors & Collaborators

• Bahir Dar University: lead

Study Sites (1)

Dessie Comprehensive Specialized Hospital

Dessie, 1145, Ethiopia

RECRUITING

Related Publications (1)

• Hussien FM, Hassen AM, Asfaw ZA, Ahmed AY, Hassen HY. The effect of mobile text messages on knowledge and perception towards cancer and behavioral risks among college students, Northeast Ethiopia: A randomized controlled trial protocol. PLoS One. 2021 Jul 9;16(7):e0253839. doi: 10.1371/journal.pone.0253839. eCollection 2021.

  PMID: 34242256 BACKGROUND

Central Study Contacts

Foziya Hussien

CONTACT

251913714985; foziyamohammed2018@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 20, 2026
• Study Start: April 13, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Locations

ET (1)