Cardiometabolic DiseasesNCT07712900
Nutrition Counselling for Cardiometabolic Multimorbidity
A study testing COM-B Model-Based Nutrition Counselling in people with Cardiometabolic Diseases, run by Bahir Dar University at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiometabolic Diseases
- What is being tested?
- COM-B Model-Based Nutrition Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteEthiopia
- Study dates
- 13 Apr 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women. Lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
Dessie Comprehensive Specialized Hospital
Dessie, 1145
Foziya Hussien, 251913714985, foziyamohammed2018@gmail.com
foziyamohammed2018@gmail.com
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cardiometabolic Diseases
- Being tested
- COM-B Model-Based Nutrition Counselling
- Keywords
- Cardiometabolic Multimorbidity, Cardiometabolic Comorbidity, Nutrition Counselling, Dietary Adherence, Nutrition-related Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COM-B Model-Based Nutrition CounsellingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 2 weeks after completion of the 3-month intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start13 Apr 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahir Dar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Foziya Mohammed Hussien, Bahir Dar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712900
- Sponsor's protocol ID
- 5087/20256
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 34242256
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07712900
- Acronym / sponsor ID
- 5087/20256
- Conditions
- Cardiometabolic Diseases
- Keywords
- Cardiometabolic Multimorbidity, Cardiometabolic Comorbidity, Nutrition Counselling, Dietary Adherence, Nutrition-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Bahir Dar UniversityUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COM-B Model-Based Nutrition Counselling | Experimental | Behavioral: COM-B Model-Based Nutrition CounsellingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnant women. Lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COM-B Model-Based Nutrition CounsellingThe 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. | Behavioural | COM-B Model-Based Nutrition Counselling |
Primary outcome
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).
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.
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.
1 secondary outcome
Nutrition-related Quality of Life
Time frame: From baseline to 2 weeks after completion of the 3-month intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 34242256Hussien 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COM-B Model-Based Nutrition Counselling in people with Cardiometabolic Diseases, run by Bahir Dar University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Foziya Hussien (251913714985, foziyamohammed2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary Adherence (time frame: From enrollment to the end of intervention at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07712900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.