Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UG3HL152381 | U.S. NIH Grant/Contract | View source | |
| UH3HL152381 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Abuja Teaching Hospital | OTHER |
| The George Institute | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| 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). |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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) |
| 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. |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adults will be enrolled as a single household representative from 3 states (Federal Capital Territory, Kano, and Ogun) of Nigeria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guhan Iyer, MPH | Contact | 3147479487 | guhaniyer@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mark D Huffman, MD, MPH | Washington University School of Medicine | Principal Investigator |
| Dike B Ojji, MD, PhD | University of Abuja Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Medical Centre | Recruiting | Abeokuta | Ogun State | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41971375 | Derived | 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. |
Not provided
Not provided
Individual participant data will be shared through NHLBI BioLINCC.
Data will be available within 1 year of study conclusion.
Access to study data will be managed through NHLBI BioLINCC
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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) |
| 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) |
| University of Abuja Teaching Hospital | Recruiting | Gwagwalada | Nigeria |
|
| Aminu Kano Teaching Hospital | Recruiting | Kano | Nigeria |
|