- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05549388
Effect of Front-of-Pack Labels in Ethiopia
Effect of Front-of-Package Labels on the Intent to Purchase Packaged Foods in Ethiopia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In 2017, cardiovascular disease was the leading age-standardized cause of death in Ethiopia. The national prevalence of hypertension in Ethiopia in 2015 is estimated to be 16% (Gebreyes et al. 2018). Urban diets are rapidly changing, but not becoming healthier (Wolle et al. 2020). Diet quality remains poor: only 2.4% of the national population meets the WHO recommendation of five servings of fruit and vegetables per day. The mean estimated salt intake of 8.3 g/day exceeds the WHO maximum recommended intake (Challa et al. 2017). Processed foods are penetrating the market at a rapid pace (Melesse et al. 2019; Stuckler et al. 2012). Increasing income has increased demand for convenience foods (Minten et al. 2018). Ethiopia is experiencing the type of rapid food system transformation that leads to a double burden of malnutrition and increased non-communicable diseases (Popkin 2017).
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 (Croker et al. 2020). However, front-of-pack labels have not been tested in the Ethiopian context. Additionally, there are multiple types of front-of-pack labeling systems in use around the world, such as Multiple Traffic Light/Guideline Daily Amounts, the Nutri-Score system, and nutrient-specific warning labels.
Therefore, the study aims to 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oromia Region
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Addis Ababa, Oromia Region, Ethiopia
- Street-Intercept Survey
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥18 years
- Purchase foods outside of the household
Exclusion Criteria:
- Age <18 years
- Do not purchase foods outside of the household
- Unable to complete the survey protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No label
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.
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Experimental: Multiple Traffic Light (MTL)
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.
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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.
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Experimental: Nutri-Score
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.
|
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.
|
|
Experimental: Warning Label
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intent to purchase based on single product tasks
Time Frame: The outcome will be assessed during survey administration at a single time point (baseline).
|
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.
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The outcome will be assessed during survey administration at a single time point (baseline).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Purchase choice based on product comparison tasks
Time Frame: The outcome will be assessed during survey administration at a single time point (baseline).
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The investigators will evaluate responses to three product comparison tasks, each of which will present two packaged food items in the same food category and ask respondents which product they would choose to purchase.
Specifically, the investigators will examine the proportion in each arm who report they would avoid purchasing the "less healthy" product.
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The outcome will be assessed during survey administration at a single time point (baseline).
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Label understanding and acceptability
Time Frame: The outcome will be assessed during survey administration at a single time point (baseline).
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In the warning label, multiple traffic light, and Nutriscore arms, participants will be shown images of the respective labels.
They will be asked a series of questions regarding their understanding of the label and its acceptability in Ethiopia and provide responses using a likert scale.
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The outcome will be assessed during survey administration at a single time point (baseline).
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intent to purchase foods high in sodium
Time Frame: The outcome will be assessed during survey administration at a single time point (baseline).
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In exploratory analyses, the investigators will compare purchase intentions based on the single product tasks, examined separately for high sodium and high sugar products.
For each product high in sodium, 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 two products high in sodium.
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The outcome will be assessed during survey administration at a single time point (baseline).
|
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Intent to purchase foods high in sugar
Time Frame: The outcome will be assessed during survey administration at a single time point (baseline).
|
In exploratory analyses, the investigators will compare purchase intentions based on the single product tasks, examined separately for high sodium and high sugar products.
For each product high in sugar, 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 two products high in sugar.
|
The outcome will be assessed during survey administration at a single time point (baseline).
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00016498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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