Clinical trial NCT05973760: Dietary Assessment and Prevention of Hypertension in Nigeria
Official title: Dietary Assessment and Prevention of Hypertension in Nigeria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Blood Pressure
Keywords: diet
West Africa
nutrition
LMIC
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Rivers State University Teaching Hospital
name: Tertiary Education Trust Fund (TETFund)
First posted: 2023-08-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women deciding in Nigeria visiting River State University Teaching Hospital

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.

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.

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

Primary outcomes:
measure: Validity of Clinical food frequency questionnaire (FFQ)
timeFrame: Phase 1 (4-8 weeks)
measure: Feasibility of FFQ clinical tool in Nigerian clinic
timeFrame: Phase1 (4-8 weeks) and Phase 2 (4-8 weeks)
Secondary outcomes:
measure: Hypertension/Blood Pressure
timeFrame: Phase 2 (4 - 8 weeks)
Other outcomes:
Locations:
city: Port Harcourt
country: Nigeria
facility: Royal State University
Study officials:
affiliation: University of Leeds
name: Michael Zulyniak, PhD
role: PRINCIPAL_INVESTIGATOR
References: