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

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.

Study Overview

• Status: Recruiting
• Conditions: Dietary Sources of Sodium; Population Sodium Intake
• Intervention / Treatment: Other: SHAKE Package

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1350

Contacts and Locations

• Study Contact: Name: Guhan Iyer, MPH; Phone Number: 3147479487; Email: guhaniyer@wustl.edu

Study Locations

• Nigeria
  • Gwagwalada, Nigeria
    • Recruiting
    • University of Abuja Teaching Hospital
    • Contact: Dike Ojji
  • Kano, Nigeria
    • Recruiting
    • Aminu Kano Teaching Hospital
    • Contact: Dike Ojji
  • Ogun
    • Abeokuta, Ogun, Nigeria
      • Recruiting
      • Federal Medical Centre
      • Contact: Dike Ojji

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Adults will be enrolled as a single household representative from 3 states (Federal Capital Territory, Kano, and Ogun) of Nigeria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Wave 1; 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).	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).
Wave 2; 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).	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).
Wave 3; 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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); The George Institute; University of Abuja Teaching Hospital
• Investigators: Principal Investigator: Mark D Huffman, MD, MPH, Washington University School of Medicine; Principal Investigator: Dike B Ojji, MD, PhD, University of Abuja Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Dietary Sodium; Sodium Intake; Sodium Reduction Program
• Other Study ID Numbers: UATH/HREC/PR/2020/001; UG3HL152381 (U.S. NIH Grant/Contract); UH3HL152381 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be shared through NHLBI BioLINCC.
• IPD Sharing Time Frame: Data will be available within 1 year of study conclusion.
• IPD Sharing Access Criteria: Access to study data will be managed through NHLBI BioLINCC
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No