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

NCT04765865 | Recruiting DMC

• 3 other identifiers: UATH/HREC/PR/2020/001UG3HL152381UH3HL152381
• Study Type: observational
• Target: 1,350
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Dietary Sources of Sodium; Population Sodium Intake

Keywords

Dietary Sodium; Sodium Intake; Sodium Reduction Program

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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)

• 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)

Other Outcomes (2)

• Change in mean population systolic and diastolic blood pressure from baseline (Wave 1) to follow-up (Waves 2 and 3).

  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

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

Study Arms (3)

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

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

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

Interventions

SHAKE Package OTHER

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 1; Wave 2; Wave 3

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Abuja Teaching Hospital: collaborator
• The George Institute: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

Federal Medical Centre

Abeokuta, Ogun State, Nigeria

RECRUITING

University of Abuja Teaching Hospital

Gwagwalada, Nigeria

RECRUITING

Aminu Kano Teaching Hospital

Kano, Nigeria

RECRUITING

Study Officials

• Mark D Huffman, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Dike B Ojji, MD, PhD

  University of Abuja Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guhan Iyer, MPH

CONTACT

3147479487; guhaniyer@wustl.edu

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Global Health Center; Professor of Medicine

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 23, 2021
• Study Start: June 26, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available within 1 year of study conclusion.
• Access Criteria: Access to study data will be managed through NHLBI BioLINCC

Locations

NG (3)