Dietary Assessment and Prevention of Hypertension in Nigeria

NCT ID: NCT05973760

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-23

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. Evaluate the feasibility and validate the a short dietary screening tool for hypertension for use in Nigerian clinics; and
2. Test the accuracy and estimate the potential value of the validated short dietary assessment tool in Nigeria clinics.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypertensive

Men or women previously diagnosed with hypertension

No interventions assigned to this group

Non-hypertensive

Men or women not previously diagnosed with hypertension

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Men and women of generally good health or with hypertension

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rivers State University Teaching Hospital

UNKNOWN

Sponsor Role collaborator

Tertiary Education Trust Fund (TETFund)

UNKNOWN

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael A Zulyniak

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Zulyniak, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Leeds

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal State University

Port Harcourt, , Nigeria

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Nigeria

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nimisoere Batubo, MMBS

Role: CONTACT

01782 715444

Michael Zulyniak, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Michael Zulyniak, PhD

Role: primary

Nimisoere Batubo, MBBS

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39429509 (View on PubMed)

Batubo 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.

Reference Type DERIVED
PMID: 38662712 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RSUTH/REC/2023316

Identifier Type: OTHER

Identifier Source: secondary_id

FREC 2023-0484-572

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.