Image

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

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

Recruiting
18-69 years
All
Phase N/A

Powered by AI

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.

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.

Eligibility

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

Study details
    Dietary Sources of Sodium
    Population Sodium Intake

NCT04765865

Washington University School of Medicine

5 June 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.