Clinical trial NCT05549388: Effect of Front-of-Pack Labels in Ethiopia
Official title: Effect of Front-of-Package Labels on the Intent to Purchase Packaged Foods in Ethiopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Nutrition
Packaged food
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Addis Continental Institute of Public Health
name: Resolve to Save Lives
First posted: 2022-09-22
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intent to purchase based on single product tasks
timeFrame: The outcome will be assessed during survey administration at a single time point (baseline).
Secondary outcomes:
measure: Purchase choice based on product comparison tasks
timeFrame: The outcome will be assessed during survey administration at a single time point (baseline).
measure: Label understanding and acceptability
timeFrame: The outcome will be assessed during survey administration at a single time point (baseline).
Other outcomes:
measure: Intent to purchase foods high in sodium
timeFrame: The outcome will be assessed during survey administration at a single time point (baseline).
measure: Intent to purchase foods high in sugar
timeFrame: The outcome will be assessed during survey administration at a single time point (baseline).
Locations:
city: Addis Ababa
country: Ethiopia
facility: Street-Intercept Survey
state: Oromia Region
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.