NCT05549388

Brief Summary

Ethiopia is experiencing the type of rapid food system transformation that leads to a double burden of malnutrition and increased non-communicable diseases. Front-of-pack labels on packaged foods are an emerging public health strategy with the potential to address non-communicable diseases by discouraging the purchase and consumption of products with high levels of nutrients of public health concern. The aim of this study is to evaluate and compare the effectiveness of front-of-pack labeling systems to reduce the intent to purchase unhealthy foods among adults in Ethiopia. The study will recruit approximately 1200 adults using a street-intercept methodology. Participants will be randomized to 1 of 4 arms to complete a survey in which the presence and type of front-of-pack label differs across survey arms and asked to rate participants' intent to purchase unhealthy packaged foods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
Last Updated

January 19, 2023

Status Verified

September 1, 2022

Enrollment Period

9 days

First QC Date

September 2, 2022

Last Update Submit

January 17, 2023

Conditions

Keywords

NutritionPackaged food

Outcome Measures

Primary Outcomes (1)

  • Intent to purchase based on single product tasks

    Participants will be shown images of four single products, two of which are high in sodium and two of which are high in sugar. For each product, participants will rate their intent to purchase the product on a likert scale. The investigators will calculate the mean of the responses to questions about the four products.

    The outcome will be assessed during survey administration at a single time point (baseline).

Secondary Outcomes (2)

  • Purchase choice based on product comparison tasks

    The outcome will be assessed during survey administration at a single time point (baseline).

  • Label understanding and acceptability

    The outcome will be assessed during survey administration at a single time point (baseline).

Other Outcomes (2)

  • Intent to purchase foods high in sodium

    The outcome will be assessed during survey administration at a single time point (baseline).

  • Intent to purchase foods high in sugar

    The outcome will be assessed during survey administration at a single time point (baseline).

Study Arms (4)

No label

NO INTERVENTION

In this arm, participants will view images of packaged food or beverage products without a front-of-pack label and respond to questions about the products.

Multiple Traffic Light (MTL)

EXPERIMENTAL

In this arm, participants will view images of packaged food or beverage products which have multiple traffic light labels displayed on the front-of-pack and respond to questions about the products.

Other: Front-of-pack labeling

Nutri-Score

EXPERIMENTAL

In this arm, participants will view images of packaged food or beverage products which have a Nutriscore front-of-pack label and respond to questions about the products.

Other: Front-of-pack labeling

Warning Label

EXPERIMENTAL

In this arm, participants will view packaged food or beverage products which have front-of-pack warning labels if the product is high in one or more nutrients of concern and respond to questions about the products.

Other: Front-of-pack labeling

Interventions

The intervention being tested is the effect of front-of-package labeling on consumers' intent to purchase foods which are high in one or more nutrients of public health concern. Participants randomized to the control group will view images of packaged foods and beverages and answer a series of questions about those products. In the intervention arms, participants will view images of the same packaged foods and beverages, but with different front-of-package labels displayed that provide nutrition information about the product. Participants in each arm will be asked the same series of questions about the products shown.

Multiple Traffic Light (MTL)Nutri-ScoreWarning Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Purchase foods outside of the household

You may not qualify if:

  • Age \<18 years
  • Do not purchase foods outside of the household
  • Unable to complete the survey protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Street-Intercept Survey

Addis Ababa, Oromiya, Ethiopia

Location

Related Publications (5)

  • Croker H, Packer J, Russell SJ, Stansfield C, Viner RM. Front of pack nutritional labelling schemes: a systematic review and meta-analysis of recent evidence relating to objectively measured consumption and purchasing. J Hum Nutr Diet. 2020 Aug;33(4):518-537. doi: 10.1111/jhn.12758. Epub 2020 May 4.

    PMID: 32364292BACKGROUND
  • Popkin BM. Relationship between shifts in food system dynamics and acceleration of the global nutrition transition. Nutr Rev. 2017 Feb 1;75(2):73-82. doi: 10.1093/nutrit/nuw064. No abstract available.

    PMID: 28395033BACKGROUND
  • Gebreyes YF, Goshu DY, Geletew TK, Argefa TG, Zemedu TG, Lemu KA, Waka FC, Mengesha AB, Degefu FS, Deghebo AD, Wubie HT, Negeri MG, Tesema TT, Tessema YG, Regassa MG, Eba GG, Beyene MG, Yesu KM, Zeleke GT, Mengistu YT, Belayneh AB. Prevalence of high bloodpressure, hyperglycemia, dyslipidemia, metabolic syndrome and their determinants in Ethiopia: Evidences from the National NCDs STEPS Survey, 2015. PLoS One. 2018 May 9;13(5):e0194819. doi: 10.1371/journal.pone.0194819. eCollection 2018.

    PMID: 29742131BACKGROUND
  • Challa F, Tadesse Y, Mudie K, et al. Urinary Sodium Excretion and Determinants among Adults in Ethiopia: Findings from National STEPS Survey. Ethiopian Journal of Health Development. 2017; 31(1):370-77.

    BACKGROUND
  • Stuckler D, McKee M, Ebrahim S, Basu S. Manufacturing epidemics: the role of global producers in increased consumption of unhealthy commodities including processed foods, alcohol, and tobacco. PLoS Med. 2012;9(6):e1001235. doi: 10.1371/journal.pmed.1001235. Epub 2012 Jun 26.

    PMID: 22745605BACKGROUND

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The statistical analyst will be masked to the study arms during the analysis phase.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 22, 2022

Study Start

December 28, 2022

Primary Completion

January 6, 2023

Study Completion

January 6, 2023

Last Updated

January 19, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

The investigators will only share deidentified data.

Locations