Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHAKE Package.
- Who it may be relevant to
- Registry conditions: Dietary Sources of Sodium, Population Sodium Intake. Basic parameters: 18 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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).
Primary outcome measures
- 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 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)]
Secondary outcome measures (2)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Ecologic or community
Study locations
Nigeria · 3 centers
- Federal Medical Centre — Abeokuta
- University of Abuja Teaching Hospital — Gwagwalada
- Aminu Kano Teaching Hospital — Kano
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 in PMID 41971375
Identifiers
NCT: NCT04765865 · UATH/HREC/PR/2020/001 · UG3HL152381 · UH3HL152381