Assessing the effectiveness of front-of-pack food labels in Kenya

ISRCTN	ISRCTN82491256
DOI	https://doi.org/10.1186/ISRCTN82491256
Secondary identifying numbers	ERC/P1323/2022

Submission date: 28/11/2023
Registration date: 06/12/2023
Last edited: 24/02/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Kenya has a high rate of unhealthy food consumption because there are no comprehensive policies in place to regulate the food environment. The main objective of the study is to evaluate the effect of different front-of-pack labels on participants' identification of products high in nutrients of concern, identification of unhealthy foods, and intention to purchase unhealthy foods and beverages.

Who can participate?
Adults over the age of eighteen years who are not employed by marketing firms, food and beverage companies, health promotion organizations, the tobacco industry, or the food and beverage sector (grocery stores, eateries, etc.)

What does the study involve?
This research involves the comparison and identification of a front-of-pack label that most effectively improves nutrient comprehension among the Kenyan population.

What are the possible benefits and risks of participating?
No individual benefits are anticipated from participation in this study. The proposed study is expected to provide evidence for public policy, and participants will be duly informed of this. The study poses minimal risks to the participants.

Where is the study run from?
African Population and Health Research Center (APHRC) (Kenya)

When is the study starting and how long is it expected to run for?
March 2022 to January 2024

Who is funding the study?
1. International Development Research Centre (Canada)
2. Rockefeller Foundation (USA)

Who is the main contact?
Dr Gershim Asiki, gasiki@aphrc.org
Shukri Mohammed, smohamed@aphrc.org

Contact information

Dr Gershim Asiki
Principal Investigator

African Population and Health Research Center (APHRC)
P.O BOX, 10787
Nairobi
00100
Kenya

ORCID ID	0000-0002-9966-1153
Phone	+254 714712834
Email	gasiki@aphrc.org

Dr Shukri Mohammed
Public, Scientific

African Population and Health Research Center (APHRC)
P.O BOX, 10787
Nairobi
00100
Kenya

ORCID ID	0000-0002-8693-1943
Phone	+254 713089457
Email	smohamed@aphrc.org

Study information

Study design	Three-arm randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community, Retail/food outlet
Study type	Prevention, Efficacy
Participant information sheet	44656 PIS.pdf
Scientific title	Assessing the effectiveness of front-of-pack food labels in Kenya: A randomized controlled trial
Study acronym	FEP-ACTION
Study hypothesis	The presence of a Front-of-Pack Label will lead to a higher rate of correct identification of unhealthy foods by consumers compared to a condition where no label is present.
Ethics approval(s)	Approved 24/04/2023, AMREF Ethics and Scientific Review Commitee (Nairobi, Nairobi, 00100, Kenya; +254(0) 206994000; erc.kenya@amreg.org), ref: ERC/P1323/2022
Condition	Identification of unhealthy foods using different front-of-pack labels in urban and rural settings in Kenya
Intervention	The intervention involves two phases: a control (placebo) phase and an experimental phase. Each participant will be exposed to both the control and experimental phases, with the aim of assessing the within- and between-subject effects. During the control (placebo) phase, all participants will view product images displayed on mock packages without any front-of-pack label. Subsequently, they will respond to a set of questions. In the experimental phase, the same participants will be randomly assigned to one of three label conditions (intervention or experiment). They will view the same product images, but this time the images will be presented with a front-of-pack label (the intervention), and they will be asked to respond to the same identical set of questions as in the control phase. The study duration is approximately is one month, and there will be no subsequent follow-up for the study arms. In terms of randomization, a manual process utilizing an Excel sheet will be used to randomly allocate study participants to one of three front-of-pack labels. The initial step involves using the sample allocation for counties and sub-counties to ensure an equal distribution of labels among participants in those specific counties. Participants will then be assigned labels randomly based on their specific unique IDs. This process will be imported into the data collection equipment, and random symbols will appear for each participant during the interviews.
Intervention type	Behavioural
Primary outcome measure	Measured during the control and intervention phases: 1. Identification of foods high in nutrients of concern measured by presenting products and asking the participant to identify the products that are high in salt, sugar, and fat (yes, no, or don’t know) and identify the products as unhealthy (healthy or unhealthy) 2. Identification of unhealthy foods measured by presenting paired images of products and asking the participant to identify the product higher in salt, sugar, or fat and determine the unhealthier product. 3. Consumers intention to purchase unhealthy foods measured using a four-point Likert scale.
Secondary outcome measures	There are no secondary outcome measures
Overall study start date	01/03/2022
Overall study end date	31/01/2024

Eligibility

Participant type(s)	Resident, Population
Age group	Adult
Lower age limit	18 Years
Upper age limit	69 Years
Sex	Both
Target number of participants	2,185
Total final enrolment	2196
Participant inclusion criteria	Participants >18 years and those who purchase packaged products.
Participant exclusion criteria	1. Participants aged less than 18 years 2. Participants working in the marketing industry, food and beverage companies, health promotion, tobacco industry, and food and beverage industry (e.g., supermarkets, restaurants, retail companies)
Recruitment start date	29/11/2023
Recruitment end date	22/12/2023

Locations

Countries of recruitment

Kenya

Study participating centres

Nairobi County

Embakasi North and South counties, and Langata sub counties
Nairobi
00100
Kenya

Mombasa County

Mvita and Kisauni Sub Counties
Mombasa
80100
Kenya

Garrisa County

Garrisa township and Fafi sub counties.
Garrisa
7 0100
Kenya

Kisumu county

Nyando and Kisumu central sub counties
Kisumu
4 0100
Kenya

Sponsor information

International Development Research Centre
Government

45 O'Connor St, Ottawa, ON K1P 1A4
Ottawa
K1G 3H9
Canada

Phone	+1 (613) 236-6163
Email	info@idrc.ca
Website	http://www.idrc.ca/EN/Pages/default.aspx

Rockefeller Foundation
Research organisation

420 Fifth Avenue
New York
NY 10018
United States of America

Phone	+1 20 4987500
Email	info@rockfound.org
Website	https://www.rockefellerfoundation.org/
"ROR"	https://ror.org/03sfkwk85

Funders

Funder type

Government

International Development Research Centre
Government organisation / Local government

Alternative name(s): Centre de recherches pour le développement international, IDRC, CRDI
Location: Canada

Rockefeller Foundation
Government organisation / Local government

Alternative name(s): Centre de recherches pour le développement international, IDRC, CRDI
Location: Canada

Results and Publications

Intention to publish date	30/12/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	We plan to publish the findings of this study in a peer-reviewed journal. The findings will also be disseminated to various audiences, including government stakeholders, civil society, communities where the data will be collected, scientific conferences, etc.
IPD sharing plan	The datasets generated during and/or analyzed during the current study will be available upon request from gasiki@aphrc.org. The shared data will be anonymized and have no identifiers linking it back to the study participants. Broad consent will be sought from the study participants thus allowing for future analysis.

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet		01/12/2023	No	Yes
Basic results	24/10/2024	28/10/2024	No	No
Results article	10/11/2024	24/02/2025	Yes	No

Additional files

44656 PIS.pdf
ISRCTN82491256_BasicResults_24OCT24_CK.pdf

Editorial Notes

24/02/2025: Publication reference added. The overall study end date was changed from 31/01/2025 to 31/01/2024.
28/10/2024: The basic results have been uploaded as an additional file.
11/01/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 20/01/2024 to 22/12/2023.
2. The total final enrolment was added.
01/12/2023: Trial's existence confirmed by Amref