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临床试验/NCT04765865
NCT04765865招募中不适用

Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program

Washington University School of Medicine3 个研究点 分布在 1 个国家目标入组 1,350 人开始时间: 2023年6月26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
1,350
试验地点
3
主要终点
Change in 24-hour urinary sodium from baseline (Wave 1) to follow-up (Wave 3)

研究概览

简要总结

The NaSS aims to assess the extent to which the SHAKE program is implemented within Nigeria by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC) using a type III hybrid, mixed method study design.

详细描述

The Nigerian Agency for Food and Drug Administration and Control (NAFDAC) is leading implementation and scale-up of a national sodium reduction program with other national, state, and international agencies using the WHO's "Best Buy" SHAKE package (Surveillance of salt intake, Harness industry, Adopt standards for labelling and marketing, Knowledge to empower consumers, and Environments to promote healthy eating). SHAKE provides evidence-based recommendations for population-wide sodium reduction interventions for hypertension prevention and control.

The Nigeria Sodium Study will support this program's implementation and scale-up by evaluating the extent to which the program is implemented using a type III hybrid, mixed methods study design through repeated: 1) stakeholder interviews, 2) populations surveys, and 3) retail surveys. Implementation research methods will be used during adaptation, planning, and initial implementation for baseline (Wave 1) and follow-up Waves 2 and 3) assessments. A dietary sources of sodium study will also be performed at baseline and Wave 3 follow-up to target/track sodium reduction efforts according to local context and culture. Food retail surveys over the study period will capture novel data on packaged, unpackaged, and informal restaurant/hawker food through the international FoodSwitch program, which combines a consumer facing tool with crowdsourcing to better define Nigeria's food supply.

Investigators will use the Exploration, Preparation, Implementation and Sustainment (EPIS) framework throughout both phases. The formative research period will include Exploration and Preparation, when investigators will perform quantitative and qualitative measures of key process indicators, relevant contextual factors informed by CFIR, and relevant Proctor implementation outcomes, acceptability, feasibility and appropriateness. As implementation is started, investigators will use the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, including implementation outcomes (feasibility, fidelity, adoption, acceptability, and cost) and contextual factors associated with the Implementation and Sustainment phases.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female adults (aged 18 to 69 years)
  • Willingness to participate
  • Permanent residents (a person who has been in the household for at least 6 months) of the study area
  • Ability to provide informed consent

排除标准

  • Individuals who are unable to provide informed consent
  • Pregnant women, and those who are breastfeeding and/or women menstruating at the time of collection
  • Cognitively impaired adults
  • Those with known history of heart or kidney failure, stroke, liver disease
  • Those who recently began therapy with diuretics (less than two weeks)
  • Any other conditions that would make 24-hour urine collection difficult
  • Individuals who are not yet adults (minors): i.e. infants, children, or teenagers <18 years old
  • Prisoners or other detained individuals

结局指标

主要结局

Change in 24-hour urinary sodium from baseline (Wave 1) to follow-up (Wave 3)

时间窗: Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)

Change in mean population sodium intake from baseline (Wave 1) to follow-up (Waves 2 and 3).

时间窗: Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)

Change in mean population sodium intake by age, sex, state, rurality, and presence of hypertension subgroups from baseline to Wave 2 and Wave 3 follow-up

次要结局

  • Changes in self-reported knowledge, attitudes, and behavior about harms associated with excess sodium intake from baseline (Wave 1) to follow-up (Wave 3)(Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline))
  • Change in overall and relative amount of dietary sources of sodium from baseline (Wave 1) to follow-up (Wave 3)(Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline))

研究者

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

Mark Huffman

Co-Director, Global Health Center; Professor of Medicine

Washington University School of Medicine

研究点 (3)

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