Dietary Assessment and Prevention of Hypertension in Nigeria

Hypertension Clinical Trial

Official title:

Dietary Assessment and Prevention of Hypertension in Nigeria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05973760
• Other study ID #: FREC 2023-0484-572
• Secondary ID: RSUTH/REC/202331
• Status: Recruiting
• Start date: July 23, 2023
• Est. completion date: February 2024

Study information

• Verified date: July 2023
• Source: University of Leeds
• Contact: Nimisoere Batubo, MMBS
• Phone: 01782 715444
• Email: fsnpb[@]leeds.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Locations

Country	Name	City	State
Nigeria	Royal State University	Port Harcourt

Sponsors (3)

Lead Sponsor	Collaborator
University of Leeds	Rivers State University Teaching Hospital, Tertiary Education Trust Fund (TETFund)

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Hypertension/Blood Pressure	Association between FFQ clinical tool and blood pressure	Phase 2 (4 - 8 weeks)