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

The Washington University

Status: Enrolling

Conditions: Population Sodium Intake; Dietary Sources of Sodium

Treatments: Other: SHAKE Package

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04765865

UATH/HREC/PR/2020/001

UH3HL152381 (U.S. NIH Grant/Contract)

UG3HL152381 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,350 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,350 participants in 3 patient groups

Wave 1

Description:

Participants will be enrolled as a single adult household representative from 3 states (Federal Capital Territory, Kano, Ogun) of Nigeria to complete a STEPs survey, 24-hour and spot urine assessments, blood sample collection for fatty acid estimation, and four (4) 24-hour dietary recalls (n=450).

Treatment:

Other: SHAKE Package

Wave 2

Description:

Participants will be enrolled as a single adult household representative from 3 states (Federal Capital Territory, Kano, Ogun) of Nigeria to complete a STEPs survey and 24-hour and spot urine assessments (n=450).

Treatment:

Other: SHAKE Package

Wave 3

Description:

Participants will be enrolled as a single adult household representative from 3 states (Federal Capital Territory, Kano, Ogun) of Nigeria to complete a STEPs survey, 24-hour and spot urine assessments, and four (4) 24-hour dietary recalls (n=450).

Treatment:

Other: SHAKE Package