HypertensionNCT05973760
Dietary Assessment and Prevention of Hypertension in Nigeria
An observational study of Hypertension and Blood Pressure, run by University of Leeds at 1 site in Nigeria.
Trial summary
Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa and, currently, there are no simple dietary assessment tools for clinicians to offer personalized dietary support to their patients. This study aims to: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Blood Pressure
- How many people
- 125 participants
- Where
- 1 siteNigeria
- Study dates
- 23 Jul 2023to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women deciding in Nigeria visiting River State University Teaching Hospital
Who may be able to join
- Men and women of generally good health or with hypertension
Who cannot join
- history of chronic diseases such as cardiovascular diseases (heart diseases), stroke, chronic kidney diseases, or pregnant or breastfeeding women, children below 18 years and adults above 70 years are also excluded from this study. Additionally, individuals who have made significant changes to their diet in the past six months or are currently following specific dietary restrictions will also be excluded from this study
Trial locations and contacts
1 site in 1 country.
Michael Zulyniak, PhD contact
Nigeria1 site, 1 recruiting
- Recruiting
Royal State University
Port Harcourt
Michael Zulyniak, PhD, prcmaz@leeds.ac.uk
Nimisoere Batubo, MBBS, fsnpb@leeds.ac.uk
About this study
Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa and, currently, there are no simple dietary assessment tools for clinicians to offer personalized dietary support to their patients. This study aims to:
- Evaluate the feasibility and validate the a short dietary screening tool for hypertension for use in Nigerian clinics; and
- Test the accuracy and estimate the potential value of the validated short dietary assessment tool in Nigeria clinics.
Read the detailed description
Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa. With a transition from whole foods to processed foods in Nigeria, diet is considered a key driver of hypertension. To combat this, the national nutritional guidelines in Nigeria were implemented but their translation into actionable tools for clinicians remains a challenge. Currently, there are no simple dietary assessment tools that are concise and suitable to be incorporated into clinical care without requiring extensive data analysis while still providing personalized dietary support to their patients. This study aims to deliver a clinically tested and validated short dietary assessment tool for clinicians, patients, and researchers across Nigeria to provide personalised dietary advice for patients with hypertension.
The study will be conducted in two phases: Phase 1 (n=75), will investigate the feasibility of the short FFQ and its agreement with 24-hour dietary recalls (3x) in a clinical setting in Nigeria. During the analysis of Phase 1 data, a scoring system will be developed based on the associations between individual food items in the FFQ and measures of hypertension. Phase 2 (n=50) will assess the acceptability of the FFQ and validate the association between the FFQ score and hypertension.
We anticipate that the development of a clinically tested and validated short food frequency questionnaire that will be ready for implementation analysis for use by clinicians, patients, and researchers across Nigerian that will support the prevention and management of hypertension.
- Conditions
- Hypertension, Blood Pressure
- Keywords
- diet, West Africa, nutrition, LMIC
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive | Men or women previously diagnosed with hypertension | |
| Non-hypertensive | Men or women not previously diagnosed with hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of Clinical food frequency questionnaire (FFQ)
Demonstrate the ability of a novel short clinical FFQ to accurately reflect diet habits
Measured: Phase 1 (4-8 weeks)
Feasibility of FFQ clinical tool in Nigerian clinic
Do patients, clinicians, and nurses see value in the tool in a clinical setting and accepting of it's use in the clinic
Measured: Phase1 (4-8 weeks) and Phase 2 (4-8 weeks)
Secondary outcomes (1)
Hypertension/Blood Pressure
Association between FFQ clinical tool and blood pressure
Measured: Phase 2 (4 - 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start23 Jul 2023
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Rivers State University Teaching Hospital, Nigeria, Tertiary Education Trust Fund (TETFund)
- Responsible party
- Principal investigator, Michael A Zulyniak, University of Leeds
- Investigators
- Michael Zulyniak, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973760
- Sponsor's protocol ID
- FREC 2023-0484-572
- Other IDs
- RSUTH/REC/2023316
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data
Publications
Batubo NP, Auma CI, Moore JB, Zulyniak MA. Relative Validity and Reproducibility of a Dietary Screening Tool in Nigerian Health Care. Curr Dev Nutr. 2024 Sep 20;8(10):104459. doi: 10.1016/j.cdnut.2024.104459. eCollection 2024 Oct.
PubMed 39429509Batubo NP, Nwanze NM, Alikor CA, Auma CI, Moore JB, Zulyniak MA. Empowering healthcare professionals in West Africa-A feasibility study and qualitative assessment of a dietary screening tool to identify adults at high risk of hypertension. PLoS One. 2024 Apr 25;19(4):e0294370. doi: 10.1371/journal.pone.0294370. eCollection 2024.
PubMed 38662712
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Assessment and Prevention of Hypertension in Nigeria
- ClinicalTrials.gov ID
- NCT05973760
- Acronym / sponsor ID
- FREC 2023-0484-572
- Conditions
- Hypertension, Blood Pressure
- Keywords
- diet, West Africa, nutrition, LMIC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Rivers State University Teaching Hospital, Nigeria, Tertiary Education Trust Fund (TETFund)
- Study start
- 23 Jul 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 3 Aug 2023 (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.
Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa and, currently, there are no simple dietary assessment tools for clinicians to offer personalized dietary support to their patients. This study aims to:
- Evaluate the feasibility and validate the a short dietary screening tool for hypertension for use in Nigerian clinics; and
- Test the accuracy and estimate the potential value of the validated short dietary assessment tool in Nigeria clinics.
Detailed description
Contrary to North America and Europe, the prevalence of hypertension is rising in West Africa. With a transition from whole foods to processed foods in Nigeria, diet is considered a key driver of hypertension. To combat this, the national nutritional guidelines in Nigeria were implemented but their translation into actionable tools for clinicians remains a challenge. Currently, there are no simple dietary assessment tools that are concise and suitable to be incorporated into clinical care without requiring extensive data analysis while still providing personalized dietary support to their patients. This study aims to deliver a clinically tested and validated short dietary assessment tool for clinicians, patients, and researchers across Nigeria to provide personalised dietary advice for patients with hypertension.
The study will be conducted in two phases: Phase 1 (n=75), will investigate the feasibility of the short FFQ and its agreement with 24-hour dietary recalls (3x) in a clinical setting in Nigeria. During the analysis of Phase 1 data, a scoring system will be developed based on the associations between individual food items in the FFQ and measures of hypertension. Phase 2 (n=50) will assess the acceptability of the FFQ and validate the association between the FFQ score and hypertension.
We anticipate that the development of a clinically tested and validated short food frequency questionnaire that will be ready for implementation analysis for use by clinicians, patients, and researchers across Nigerian that will support the prevention and management of hypertension.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertensive | – | –Men or women previously diagnosed with hypertension |
| Non-hypertensive | – | –Men or women not previously diagnosed with hypertension |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women deciding in Nigeria visiting River State University Teaching Hospital
Key inclusion criteria (1 listed)
- Men and women of generally good health or with hypertension
Key exclusion criteria (1 listed)
- history of chronic diseases such as cardiovascular diseases (heart diseases), stroke, chronic kidney diseases, or pregnant or breastfeeding women, children below 18 years and adults above 70 years are also excluded from this study. Additionally, individuals who have made significant changes to their diet in the past six months or are currently following specific dietary restrictions will also be excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity of Clinical food frequency questionnaire (FFQ)
Time frame: Phase 1 (4-8 weeks)
Demonstrate the ability of a novel short clinical FFQ to accurately reflect diet habits
Feasibility of FFQ clinical tool in Nigerian clinic
Time frame: Phase1 (4-8 weeks) and Phase 2 (4-8 weeks)
Do patients, clinicians, and nurses see value in the tool in a clinical setting and accepting of it's use in the clinic
1 secondary outcome
Hypertension/Blood Pressure
Time frame: Phase 2 (4 - 8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 39429509Batubo NP, Auma CI, Moore JB, Zulyniak MA. Relative Validity and Reproducibility of a Dietary Screening Tool in Nigerian Health Care. Curr Dev Nutr. 2024 Sep 20;8(10):104459. doi: 10.1016/j.cdnut.2024.104459. eCollection 2024 Oct.
- Derived from this study: PubMed 38662712Batubo NP, Nwanze NM, Alikor CA, Auma CI, Moore JB, Zulyniak MA. Empowering healthcare professionals in West Africa-A feasibility study and qualitative assessment of a dietary screening tool to identify adults at high risk of hypertension. PLoS One. 2024 Apr 25;19(4):e0294370. doi: 10.1371/journal.pone.0294370. eCollection 2024.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data
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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. This study is not recruiting at the moment.
Michael Zulyniak, PhD contact
Michael Zulyniak, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Blood Pressure, run by University of Leeds at 1 site in Nigeria.
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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. 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 Nigeria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimisoere Batubo, MMBS (01782 715444, fsnpb@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of Clinical food frequency questionnaire (FFQ) (time frame: Phase 1 (4-8 weeks)). The study lists 2 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 NCT05973760, which also lists 2 linked publications.
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 3 Aug 2023.