Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04765865
Status:
RECRUITING
Last Update Posted:
2023-08-16
First Post:
2021-02-18
Brief Title:
Evaluating Implementation and Scale-Up of Nigerias National Sodium Reduction Program
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Evaluating Implementation and Scale-Up of Nigerias National Sodium Reduction Program
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NaSS
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
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 WHOs 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 programs 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 targettrack 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 restauranthawker food through the international FoodSwitch program which combines a consumer facing tool with crowdsourcing to better define Nigerias 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
The Nigeria Sodium Study will support this programs 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 targettrack 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 restauranthawker food through the international FoodSwitch program which combines a consumer facing tool with crowdsourcing to better define Nigerias 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG3HL152381 | NIH | None | None |
| UH3HL152381 | NIH | None | httpsreporternihgovquickSearchUH3HL152381 |