Dietary Assessment and Prevention of Hypertension in Nigeria | NCT05973760

Studies
Dietary Assessment and Prevention of Hypertension in Nigeria

NCT05973760

Sponsor

University of Leeds

Status

Unknown status

Last Update Posted

Aug 3, 2023Actual

Enrollment

125Estimated

Phase

Not provided

Conditions

Hypertension
Blood Pressure

Interventions

Not provided

Countries

Nigeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
RSUTH/REC/2023316	Other Identifier	Rivers State University Teaching Hospital, Nigeria

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 23, 2023Actual

Primary Completion Date

Feb 2024Estimated

Completion Date

Feb 2024Estimated

First Submitted Date

Jul 25, 2023

First Submission Date that Met QC Criteria

Jul 25, 2023

First Posted Date

Aug 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2023

Last Update Posted Date

Aug 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael A Zulyniak, Dr., University of LeedsPrincipal Investigator

Lead Sponsor

University of LeedsOTHER

Collaborators

Name	Class
Rivers State University Teaching Hospital	UNKNOWN
Tertiary Education Trust Fund (TETFund)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypertensive		Men or women previously diagnosed with hypertension
Non-hypertensive		Men or women not previously diagnosed with hypertension

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Validity of Clinical food frequency questionnaire (FFQ)	Demonstrate the ability of a novel short clinical FFQ to accurately reflect diet habits	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	Phase1 (4-8 weeks) and Phase 2 (4-8 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Hypertension/Blood Pressure	Association between FFQ clinical tool and blood pressure	Phase 2 (4 - 8 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Men and women deciding in Nigeria visiting River State University Teaching Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nimisoere Batubo, MMBS	Contact	01782 715444		fsnpb@leeds.ac.uk
Michael Zulyniak, PhD	Contact			prcmaz@leeds.ac.uk

Overall Officials

Name	Affiliation	Role
Michael Zulyniak, PhD	University of Leeds	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal State University	Recruiting	Port Harcourt			Nigeria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39429509	Derived	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.
38662712	Derived	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases