Dietary Assessment and Prevention of Hypertension in Nigeria

Sponsor

University of Leeds (Other)

Overall Status

Recruiting

CT.gov ID

NCT05973760

Collaborator

Rivers State University Teaching Hospital (Other), Tertiary Education Trust Fund (TETFund) (Other)

125

Enrollment

Location

6.3

Anticipated Duration (Months)

19.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated Enrollment :

125 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

Dietary Assessment and Prevention of Hypertension in Nigeria

Actual Study Start Date :

Jul 23, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Hypertensive Men or women previously diagnosed with hypertension
Non-hypertensive Men or women not previously diagnosed with hypertension

Outcome Measures

Primary Outcome Measures

Validity of Clinical food frequency questionnaire (FFQ) [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 [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

Hypertension/Blood Pressure [Phase 2 (4 - 8 weeks)]
Association between FFQ clinical tool and blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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