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Dietary Assessment and Prevention of Hypertension in Nigeria

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ClinicalTrials.gov Identifier: NCT05973760
Recruitment Status : Recruiting
First Posted : August 3, 2023
Last Update Posted : August 3, 2023
Sponsor:
Collaborators:
Rivers State University Teaching Hospital
Tertiary Education Trust Fund (TETFund)
Information provided by (Responsible Party):
Michael A Zulyniak, University of Leeds

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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:

  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.

Condition or disease
Hypertension Blood Pressure

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
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Dietary Assessment and Prevention of Hypertension in Nigeria
Actual Study Start Date : July 23, 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Hypertensive
Men or women previously diagnosed with hypertension
Non-hypertensive
Men or women not previously diagnosed with hypertension


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Hypertension/Blood Pressure [ Time Frame: Phase 2 (4 - 8 weeks) ]
    Association between FFQ clinical tool and blood pressure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women deciding in Nigeria visiting River State University Teaching Hospital
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05973760


Contacts
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Contact: Nimisoere Batubo, MMBS 01782 715444 fsnpb@leeds.ac.uk
Contact: Michael Zulyniak, PhD prcmaz@leeds.ac.uk

Locations
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Nigeria
Royal State University Recruiting
Port Harcourt, Nigeria
Contact: Michael Zulyniak, PhD       prcmaz@leeds.ac.uk   
Contact: Nimisoere Batubo, MBBS       fsnpb@leeds.ac.uk   
Principal Investigator: Michael Zulyniak, PhD         
Sub-Investigator: Nimisoere Batubo, MMBS         
Sponsors and Collaborators
University of Leeds
Rivers State University Teaching Hospital
Tertiary Education Trust Fund (TETFund)
Investigators
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Principal Investigator: Michael Zulyniak, PhD University of Leeds
  Study Documents (Full-Text)

Documents provided by Michael A Zulyniak, University of Leeds:
Study Protocol  [PDF] July 19, 2023

More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Michael A Zulyniak, Dr., University of Leeds
ClinicalTrials.gov Identifier: NCT05973760    
Other Study ID Numbers: FREC 2023-0484-572
RSUTH/REC/2023316 ( Other Identifier: Rivers State University Teaching Hospital, Nigeria )
First Posted: August 3, 2023    Key Record Dates
Last Update Posted: August 3, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael A Zulyniak, University of Leeds:
diet
West Africa
nutrition
LMIC
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases