Dietary Sources of SodiumNaSSNCT04765865
Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
An observational study of Dietary Sources of Sodium and Population Sodium Intake, run by Washington University School of Medicine at 3 sites in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Sources of Sodium, Population Sodium Intake
- What is being tested?
- SHAKE Package
- How many people
- 1,350 participants
- Where
- 3 sitesNigeria
- Study dates
- 26 Jun 2023to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults will be enrolled as a single household representative from 3 states (Federal Capital Territory, Kano, and Ogun) of Nigeria.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria3 sites, 3 recruiting
- Recruiting
Federal Medical Centre
Abeokuta, Ogun State
Dike Ojji
- Recruiting
University of Abuja Teaching Hospital
Gwagwalada
Dike Ojji
- Recruiting
Aminu Kano Teaching Hospital
Kano
Dike Ojji
About this study
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.
Read the 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.
- Being tested
- SHAKE Package
- Keywords
- Dietary Sodium, Sodium Intake, Sodium Reduction Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHAKE PackageOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Other: SHAKE Package |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
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.
Measured: 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.
Measured: Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start26 Jun 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary Sources of SodiumStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Abuja Teaching Hospital, The George Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mark Huffman, Washington University School of Medicine
- Investigators
- Mark D Huffman, MD, MPH, Principal investigator, Washington University School of MedicineDike B Ojji, MD, PhD, Principal investigator, University of Abuja Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765865
- Sponsor's protocol ID
- NaSS_202306135
- Other IDs
- UG3HL152381, UH3HL152381
- Acronym
- NaSS
- Status last verified
- Nov 2026
- First submitted
- 18 Feb 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared through NHLBI BioLINCC.
Publications
Obiezu-Umeh C, Alfa V, Okoro CE, Orji IA, Nwaozuru U, Van Horn LV, Jamro EL, Ripiye N, Shedul GL, Okpetu EI, Ojo A, Ekechi H, Alex-Okoh M, Chukwuma A, Maduforo AN, Adurosakin F, Odoh D, Toma MM, Sopekan A, Uwakmfon U, John D, Iyer G, Neal B, Jones A, Trieu K, Marklund M, Tian M, Huffman MD, Ojji DB, Hirschhorn LR. Assessing the implementation of national sodium reduction policies in Nigeria: an interim qualitative evaluation of stakeholder perspectives. Front Nutr. 2026 Mar 26;13:1704402. doi: 10.3389/fnut.2026.1704402. eCollection 2026.
PubMed 41971375
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
- ClinicalTrials.gov ID
- NCT04765865
- Acronym / sponsor ID
- NaSS / NaSS_202306135
- Keywords
- Dietary Sodium, Sodium Intake, Sodium Reduction Program
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Abuja Teaching Hospital, The George Institute, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wave 1 | – | Other: SHAKE PackageParticipants 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). |
| Wave 2 | – | Other: SHAKE PackageParticipants 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). |
| Wave 3 | – | Other: SHAKE PackageParticipants 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). |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults will be enrolled as a single household representative from 3 states (Federal Capital Territory, Kano, and Ogun) of Nigeria.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHAKE PackageThe 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). | Other | Wave 1, Wave 2, Wave 3 |
Primary outcome
Change in mean population sodium intake from baseline (Wave 1) to follow-up (Waves 2 and 3).
Time frame: 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
Change in 24-hour urinary sodium from baseline (Wave 1) to follow-up (Wave 3)
Time frame: Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
2 secondary outcomes
Change in overall and relative amount of dietary sources of sodium from baseline (Wave 1) to follow-up (Wave 3)
Time frame: 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)
Time frame: Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 41971375Obiezu-Umeh C, Alfa V, Okoro CE, Orji IA, Nwaozuru U, Van Horn LV, Jamro EL, Ripiye N, Shedul GL, Okpetu EI, Ojo A, Ekechi H, Alex-Okoh M, Chukwuma A, Maduforo AN, Adurosakin F, Odoh D, Toma MM, Sopekan A, Uwakmfon U, John D, Iyer G, Neal B, Jones A, Trieu K, Marklund M, Tian M, Huffman MD, Ojji DB, Hirschhorn LR. Assessing the implementation of national sodium reduction policies in Nigeria: an interim qualitative evaluation of stakeholder perspectives. Front Nutr. 2026 Mar 26;13:1704402. doi: 10.3389/fnut.2026.1704402. eCollection 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared through NHLBI BioLINCC.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark D Huffman, MD, MPH principal investigator
Washington University School of Medicine
Dike B Ojji, MD, PhD principal investigator
University of Abuja Teaching Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dietary Sources of Sodium and Population Sodium Intake, run by Washington University School of Medicine at 3 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valerie Graham, MPH (618-559-5514, grahamv@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean population sodium intake from baseline (Wave 1) to follow-up (Waves 2 and 3). (time frame: Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765865, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.