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

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

Sponsorer

Ledande sponsor: Northwestern University

Medarbetare: University of Abuja Teaching Hospital
The George Institute
National Heart, Lung, and Blood Institute (NHLBI)

Källa Northwestern University
Kort sammanfattning

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.

detaljerad beskrivning

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.

Övergripande status Not yet recruiting
Start datum 2021-05-01
Slutförelsedatum 2027-05-01
Primärt slutdatum 2026-12-31
Studietyp Observational
Primärt resultat
Mäta Tidsram
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 24-hour urinary sodium from baseline to Years 5-6 Baseline to Years 5-6
Sekundärt resultat
Mäta Tidsram
Change in overall and relative amount of dietary sources of sodium 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 from baseline to Years 5-6 Baseline to Years 5-6
Inskrivning 8730
Tillstånd
Intervention

Interventionstyp: Other

Interventionens namn: SHAKE Package

Beskrivning: 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).

Behörighet

Testmetod: Probability Sample

Kriterier:

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

Kön: All

Lägsta ålder: 18 Years

Högsta ålder: 69 Years

Friska volontärer: Accepts Healthy Volunteers

Övergripande officiell
Övergripande kontakt

Efternamn: Aashima Chopra, MPH

Telefon: 202-600-0465

E-post: [email protected]

Plats
Anläggning:
Federal Medical Centre | Abeokuta, Ogun, Nigeria
University of Abuja Teaching Hospital | Gwagwalada, Nigeria Dike Ojji
Aminu Kano Teaching Hospital | Kano, Nigeria
Platsländer

Nigeria

Verifieringsdatum

2021-02-01

Ansvarig part

Typ: Principal Investigator

Utredarens anslutning: Northwestern University

Utredarens fullständiga namn: Mark Huffman

Utredarens titel: Director, Institute for Global Health - Center for Global Cardiovascular Health; Quentin D. Young Professor of Health Policy; Associate Professor of Preventive Medicine (Epidemiology) and Medicine (Cardiology)

Nyckelord
Har utökad åtkomst No
Arm Group

Märka: Baseline (Years 1-2)

Beskrivning: 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) .

Märka: Interim (Year 3-4)

Beskrivning: 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).

Märka: Final (Years 5-6)

Beskrivning: 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) .

Akronym NaSS
Patientdata Yes
Information om studiedesign

Observationsmodell: Ecologic or Community

Tidsperspektiv: Prospective

Källa: ClinicalTrials.gov

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