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临床试验/NCT05973760
NCT05973760招募中不适用

Dietary Assessment and Prevention of Hypertension in Nigeria

University of Leeds1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2023年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
125
试验地点
1
主要终点
Validity of Clinical food frequency questionnaire (FFQ)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women of generally good health or with hypertension

排除标准

  • 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

结局指标

主要结局

Validity of Clinical food frequency questionnaire (FFQ)

时间窗: 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

时间窗: 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

次要结局

  • Hypertension/Blood Pressure(Phase 2 (4 - 8 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael A Zulyniak

Dr.

University of Leeds

研究点 (1)

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