NaSS: Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 (Years 1-2) and of follow-up (Years 3-4 and Years 5-6) assessments. A dietary sources of sodium study will also be performed at baseline and Years 5-6 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Baseline (Years 1-2) Participants(n=3060) will be enrolled as a single adult household representative from 3 states (Federal Capital Territory, Kano, Ogun) of Nigeria to complete a baseline STEPs survey(n=2160) , 24-hour and spot urine assessments(n=450) , and 24-hour dietary recall assessment(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).
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| Interim (Year 3-4) Participants(n=2610) will be enrolled as a single adult household representative from 3 states (Federal Capital Territory, Kano, Ogun) of Nigeria to complete a baseline STEPs survey(n=2160) 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).
|
| Final (Years 5-6) Participants(n=3060) will be enrolled as a single adult household representative from 3 states (Federal Capital Territory, Kano, Ogun) of Nigeria to complete a baseline STEPs survey(n=2160) , 24-hour and spot urine assessments(n=450) , and 24-hour dietary recall assessment(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).
|
Outcome Measures
Primary Outcome Measures
- Change in mean population sodium intake from baseline to Year 3-4 and Year 5-6. [Baseline to Years 3-4 and Years 5-6]
Change in mean population sodium intake by age, sex, state, rurality, and presence of hypertension subgroups from baseline to Year 3-4 and Year 5-6.
- Change in 24-hour urinary sodium from baseline to Years 5-6 [Baseline to Years 5-6]
Secondary Outcome Measures
- Change in overall and relative amount of dietary sources of sodium from baseline to Years 5-6 [Baseline to Years 5-6]
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 to Years 5-6 based on the dietary sources of sodium study instruments.
- Changes in self-reported knowledge, attitudes, and behavior about harms associated with excess sodium intake from baseline to Years 5-6 [Baseline to Years 5-6]
Changes in self-reported knowledge, attitudes, and behavior about harms associated with excess sodium intake by age, sex, state, rurality subgroups from baseline to Years 5-6 using based on the STEPS survey instrument.
Other Outcome Measures
- Change in mean population systolic and diastolic blood pressure from baseline to Years 3-4 and Years 5-6. [Baseline to Years 3-4 and Years 5-6]
Change in mean population systolic and diastolic blood pressure by age, sex, state, rurality subgroups.
- Change in blood pressure lowering medication use [Baseline to Years 3-4 and Years 5-6]
• Change in blood pressure lowering medication use by age, sex, state, rurality subgroups.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female adults (aged 18 to 69 years)
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Willingness to participate
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Permanent residents (a person who has been in the household for at least 6 months) of the study area
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Ability to provide informed consent
Exclusion Criteria:
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Individuals who are unable to provide informed consent
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Pregnant women, and those who are breastfeeding and/or women menstruating at the time of collection
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Cognitively impaired adults
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Those with known history of heart or kidney failure, stroke, liver disease
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Those who recently began therapy with diuretics (less than two weeks)
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Any other conditions that would make 24-hour urine collection difficult
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Individuals who are not yet adults (minors): i.e. infants, children, or teenagers <18 years old
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Prisoners or other detained individuals
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal Medical Centre | Abeokuta | Ogun | Nigeria | |
| 2 | University of Abuja Teaching Hospital | Gwagwalada | Nigeria | ||
| 3 | Aminu Kano Teaching Hospital | Kano | Nigeria |
Sponsors and Collaborators
- Washington University School of Medicine
- University of Abuja Teaching Hospital
- The George Institute
- National Heart, Lung, and Blood Institute (NHLBI)
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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- UATH/HREC/PR/2020/001
- UG3HL152381