Clinical trial NCT04765865: Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
Official title: Evaluating Implementation and Scale-Up of Nigeria's National Sodium Reduction Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dietary Sources of Sodium
Population Sodium Intake
Keywords: Dietary Sodium
Sodium Intake
Sodium Reduction Program
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Abuja Teaching Hospital
name: The George Institute
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-02-23
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults will be enrolled as a single household representative from 3 states (Federal Capital Territory, Kano, and Ogun) of Nigeria.

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 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 criteria: 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

Primary outcomes:
measure: Change in mean population sodium intake from baseline (Wave 1) to follow-up (Waves 2 and 3).
timeFrame: Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)
measure: Change in 24-hour urinary sodium from baseline (Wave 1) to follow-up (Wave 3)
timeFrame: Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
Secondary outcomes:
measure: Change in overall and relative amount of dietary sources of sodium from baseline (Wave 1) to follow-up (Wave 3)
timeFrame: Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
measure: Changes in self-reported knowledge, attitudes, and behavior about harms associated with excess sodium intake from baseline (Wave 1) to follow-up (Wave 3)
timeFrame: Baseline (Wave 1) to follow-up (Wave 3 [estimated 36 months post-baseline)
Other outcomes:
measure: Change in mean population systolic and diastolic blood pressure from baseline (Wave 1) to follow-up (Waves 2 and 3).
timeFrame: Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)
measure: Change in blood pressure lowering medication use
timeFrame: Baseline (Wave 1) to follow-up (Wave 2 [estimated 18 months post-baseline] and Wave 3 [estimated 36 months post-baseline)
Locations:
city: Abeokuta
country: Nigeria
facility: Federal Medical Centre
state: Ogun
city: Gwagwalada
country: Nigeria
facility: University of Abuja Teaching Hospital
city: Kano
country: Nigeria
facility: Aminu Kano Teaching Hospital
Study officials:
affiliation: Washington University School of Medicine
name: Mark D Huffman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Abuja Teaching Hospital
name: Dike B Ojji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: