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

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

Sponsors

Commanditaire principal: Northwestern University

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

La source Northwestern University
Bref résumé

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.

Description détaillée

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.

Situation globale Not yet recruiting
Date de début May 1, 2021
Date d'achèvement May 1, 2027
Date d'achèvement principale December 31, 2026
Type d'étude Observational
Résultat primaire
Mesure Plage de temps
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
Résultat secondaire
Mesure Plage de temps
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
Inscription 8730
État
Intervention

Type d'intervention: Other

Nom de l'intervention: SHAKE Package

La description: 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).

Admissibilité

Méthode d'échantillonnage: Probability Sample

Critères:

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

Le sexe: All

Âge minimum: 18 Years

Âge maximum: 69 Years

Volontaires en santé: Accepts Healthy Volunteers

Officiel général
Contact général

Nom de famille: Aashima Chopra, MPH

Téléphone: 202-600-0465

Email: [email protected]

Emplacement
Établissement:
Federal Medical Centre | Abeokuta, Ogun, Nigeria
University of Abuja Teaching Hospital | Gwagwalada, Nigeria Dike Ojji
Aminu Kano Teaching Hospital | Kano, Nigeria
Pays d'implantation

Nigeria

Date de vérification

February 2021

Partie responsable

Type: Principal Investigator

Affiliation des enquêteurs: Northwestern University

Nom complet de l'enquêteur: Mark Huffman

Titre d'enquêteur: 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)

Mots clés
A un accès étendu No
Groupe d'armes

Étiquette: Baseline (Years 1-2)

La description: 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) .

Étiquette: Interim (Year 3-4)

La description: 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).

Étiquette: Final (Years 5-6)

La description: 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) .

Acronyme NaSS
Données patient Yes
Informations sur la conception de l'étude

Modèle d'observation: Ecologic or Community

Perspective temporelle: Prospective

La source: ClinicalTrials.gov