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NCT Number: NCT04765865

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

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.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal Medical Centre, Abeokuta, Ogun State, Nigeria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHAKE Package

Other

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 outcomes

  1. 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 mean population sodium intake by age, sex, state, rurality, and presence of hypertension subgroups from baseline to Wave 2 and Wave 3 follow-up

  2. 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 outcomes

  1. 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)

    Change in overall and relative amount of dietary sources of sodium (e.g., inherent in food, added during preparation, added at the table, added outside the home) by age, sex, state, rurality subgroups from baseline (Wave 1) to follow-up (Wave 3) based on the dietary sources of sodium study instruments.

  2. 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)

    Changes in self-reported knowledge, attitudes, and behavior about harms associated with excess sodium intake by age, sex, state, rurality subgroups from baseline (Wave 1) to follow-up (Wave 3) using based on the STEPS survey instrument.

Other outcomes

  1. Change in mean population systolic and diastolic blood pressure 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 mean population systolic and diastolic blood pressure by age, sex, state, rurality subgroups.

  2. Change in blood pressure lowering medication use

    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 blood pressure lowering medication use by age, sex, state, rurality subgroups.

Study contacts

Contact information is provided by the study sponsor or research team.

Guhan Iyer, MPH

CONTACT

[email protected]

3147479487

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Acronym: NaSS

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Feb 23, 2021
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.