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

Dietary Sources of Sodium Clinical Trial

— NaSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04765865
• Other study ID #: UATH/HREC/PR/2020/001
• Secondary ID: UG3HL152381UH3HL
• Status: Recruiting
• Start date: June 26, 2023
• Est. completion date: May 1, 2027

Study information

• Verified date: August 2023
• Source: Washington University School of Medicine
• Contact: Guhan Iyer, MPH
• Phone: 3147479487
• Email: guhaniyer[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: May 1, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dietary Sources of Sodium
• Population Sodium Intake

Intervention

Other:
• SHAKE Package
The SHAKE (Surveillance of salt intake, Harness industry, Adopt standards for labelling and marketing, Knowledge to empower consumers, and Environments to promote health eating) package is a WHO Best Buy and is recently implemented within Nigeria by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC).

Locations

Country	Name	City	State
Nigeria	Federal Medical Centre	Abeokuta	Ogun
Nigeria	University of Abuja Teaching Hospital	Gwagwalada
Nigeria	Aminu Kano Teaching Hospital	Kano

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI), The George Institute, University of Abuja Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mean population systolic and diastolic blood pressure from baseline (Wave 1) to follow-up (Waves 2 and 3).	Change in mean population systolic and diastolic blood pressure by age, sex, state, rurality subgroups.	Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)
Other	Change in blood pressure lowering medication use	Change in blood pressure lowering medication use by age, sex, state, rurality subgroups.	Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)
Primary	Change in mean population sodium intake from baseline (Wave 1) to follow-up (Waves 2 and 3).	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	Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)
Primary	Change in 24-hour urinary sodium from baseline (Wave 1) to follow-up (Wave 3)		Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
Secondary	Change in overall and relative amount of dietary sources of sodium from baseline (Wave 1) to follow-up (Wave 3)	Change in overall and relative amount of dietary sources of sodium (e.g., inherent in food, added during preparation, added at the table, added outside the home) by age, sex, state, rurality subgroups from baseline (Wave 1) to follow-up (Wave 3) based on the dietary sources of sodium study instruments.	Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
Secondary	Changes in self-reported knowledge, attitudes, and behavior about harms associated with excess sodium intake from baseline (Wave 1) to follow-up (Wave 3)	Changes in self-reported knowledge, attitudes, and behavior about harms associated with excess sodium intake by age, sex, state, rurality subgroups from baseline (Wave 1) to follow-up (Wave 3) using based on the STEPS survey instrument.	Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)