Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404887289926 Date of Approval: 23/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of providing information on the sugar-sweetened beverage consumption of peers: a randomized trial in seven African countries
Official scientific title The effect of an information provision intervention utilizing a targeted peer comparison of sugar-sweetened beverage consumption: a cohort-nested randomized trial in seven African countries
Brief summary describing the background and objectives of the trial With 60% of the population under the age of 25, Sub-Saharan Africa (SSA) has the largest proportion of adolescents and young adults aged 10-24 worldwide. This growing population group presents a unique social and economic opportunity for the region, while at the same time, realizing this demographic dividend depends on addressing the plethora of challenges. Adolescence and the subsequent transition into adulthood is a critical stage of life when numerous key behaviors, such as diet, are established. These behaviors have immediate health implications, but also determine and shape behaviors well into adulthood and, with them, long-term health outcomes. Interventions, such as those that providing health-focused information, are needed to promote healthy behaviors in this population. The Design and Evaluation of Adolescent Health Interventions and Policies (DASH) project aims to boost adolescent and young adult health in the region through rigorous population-based intervention and policy research. Within DASH, a cohort of 14,000 adolescents and young adults from seven countries is currently being established to investigate the health and health behaviors of this population. This randomized trial will be nested within those data collection activities. We will investigate the effect of a general risk communication statement (intervention group 1) compared to a general risk communication statement plus a targeted peer comparison (intervention group 2) and no intervention (control group) concerning the intake of sugary beverages. Our a priori hypotheses are that the general risk communication statement plus a targeted peer comparison will be more effective than the generalized risk communication alone in increasing participants' intentions to reduce their sugary beverage consumption, and that the generalized risk communication alone will be more effective than no intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 22/04/2024
Actual trial start date
Anticipated date of last follow up 01/08/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 14000
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group General risk communication statement Instantaneous This will be an information intervention providing generalized risk communication on sugary beverages, in the following form: "Research in adolescents has shown that drinking sugary beverages, such as carbonated soft drinks, energy drinks and sports drinks, can negatively affect health at your age. For example, consistently drinking such beverages likely increases your risk of weight gain, dental problems, and maybe even increases the risk of more serious issues like diabetes." 4669
Experimental Group General risk communication statement plus a targeted peer comparison Instantaneous This will be an information intervention with two components. The first component will provide the same generalized risk communication on sugary beverages from Intervention 1. The second component will use previously collected data on sugar-sweetened beverage consumption from the same populations to provide a tailored peer comparison that relates their consumption to their peers' consumption, in the following form: [Example of personalized text based on the country, sex and age of participant]: "You indicated that you usually have sugary beverages one time per day per day. Previous research in Nigeria showed 72 out of 100 young women your age drink less sugary beverages per day than you."; This text will be accompanied by an pictogram showing 72 out of 100. 4669
Control Group No intervention NA This will be a pure control that receives no intervention 4662 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following inclusion criteria are those for the overall DASH cohort; no further criteria will be applied: ● Study participant is between ages 10 and 24 years; ● Minors (i.e. less than 18 years of age): the parents or guardians provide written informed consent; ● Minors: the minor participant provides informed assent; ● Adults (i.e. 18 years of age and above): provides written informed consent; and, ● Study participant is a resident of the study area and intends to stay in the study area for the duration of the study The following exclusion criteria are those for the overall DASH cohort: Participants who do not meet the above-listed criteria will be excluded; Participants with chronic illnesses will be excluded since it may hinder their autonomy; Participants whose capacity to make meaningful decisions is in question because they are "cognitively impaired”; Individuals with communication difficulties. The only additional criteria applied specifically for this randomized trial is that the participant, if allocated to intervention receive the targeted peer comparison, will be excluded if he/she does not respond to the question that is used to generate the targeted peer comparison. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year 10 Year(s) 24 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/10/2023 University of Heidelberg Ethics Committee of the Medical Faculty
Ethics Committee Address
Street address City Postal code Country
Alte Glockengiesserie 11/1 Heidelberg 69115 Germany
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/11/2023 University of Ibadan Social Sciences and Humanities Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kwara Street Ibadan 200132 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/12/2023 Comite d ethique et institutionnel de Institut national de sante publique
Ethics Committee Address
Street address City Postal code Country
Rue Goerges Ouedraogo Ouagadougou NA Burkina Faso
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/04/2024 Makerere University School of Public Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
P.O. Box 7072 Kampala 7072 Uganda
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/07/2024 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P.O Box MB 190 Accra GA050 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/04/2024 Addis Continental Institute of Public Health Institutional Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Ayat Homes Zone 8 Road 8 Addis Ababa 26751/100 Ethiopia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/05/2024 University of Kwazulu Natal Biomedical Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Private Bag X54001 Durban 4000 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 04/12/2023 National Institute for Medical Research National Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intention to change sugary beverage consumption Cross-sectionally at a later point in the survey.
Secondary Outcome Volume of sugary drinks consumed in the past 7 days 1 year after intervention is provided, when the next wave of the survey is administered
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Addis Continental Institute of Public Health Ayat Zone 8 Addis Ababa Ethiopia
Makerere University School of Public Health New Mulago Hill Road, Mulago Kampala Uganda
Nouna Health Research Centre Rue Namory Keita Nouna Burkina Faso
University of Dodoma 1 Benjamin Mkapa Road Dodoma Tanzania
University of Ghana P.O. Box LG 13 Accra Ghana
University of Ibadan Research Foundation Oduduwa Road Ibadan Nigeria
University of KwaZulu Natal College of Health Sciences Private Bag X54001 Durban South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Federal Ministry of Education and Research Kapelle-Ufer 1 Berlin 10117 Germany
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Africa Academy for Public Health 6 Msonge Street, Mikocheni Dar es Salaam 32273 Tanzania Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Technical University of Munich Georg Brauchle Ring 60/62 Munich 80992 Germany
Africa Academy for Publich Health 6 Msonge Street, Mikocheni Dar es Salaam 32273 Tanzania
Addis Continental Institute of Public Health Ayat Zone 8 Addis Ababa Ethiopia
Makerere University School of Public Health New Mulago Hill Road, Mulago Kampala Uganda
Nouna Health Research Center Rue Namory Keita Nouna Burkina Faso
University of Ibadan Research Foundation Oduduwa Road, 200132 Ibadan Nigeria
University of KwaZulu Natal Private Bag X54001 Durban 4000 South Africa
University of Dodoma 1 Benjamin Mkapa Road Dodoma Tanzania
University of Ghana P.O. Box LG 13 Accra Ghana
Heidelberg Institute of Global Health Im Neuenheimer Feld 130/3 Heidelberg 69120 Germany
Harvard T.H. Chan School of Public Health 677 Huntington Avenue Boston 02115 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jacob Burns jacob.burns@tum.de +498928924980 Georg Brauchle Ring 60/62
City Postal code Country Position/Affiliation
Munich 80992 Germany Technical University of Munich
Role Name Email Phone Street address
Public Enquiries Jacob Burns jacob.burns@tum.de +498928924980 Georg Brauchle Ring 60/62
City Postal code Country Position/Affiliation
Munich 80992 Germany Technical University of Munich
Role Name Email Phone Street address
Scientific Enquiries Jacob Burns jacob.burns@tum.de +498928924980 Georg Brauchle Ring 60/62
City Postal code Country Position/Affiliation
Munich 80992 Germany Technical University of Munich
Role Name Email Phone Street address
Principal Investigator Mary Mwanyika Sando msando@aaph.or.tz +255735166105 6 Msonge Street, Mikocheni
City Postal code Country Position/Affiliation
Dar es Salaam 32273 Tanzania Africa Academy for Public Health
Role Name Email Phone Street address
Principal Investigator Yemane Berhane yemaneberhane@gmail.com +251116390038 Ayat Zone 8
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Addis Continental Institute of Public Health
Role Name Email Phone Street address
Principal Investigator David Guwatudde dguwatudde@musph.ac.ug +256414543872 New Mulago Hill Road, Mulago
City Postal code Country Position/Affiliation
Kampala Uganda Makerere University School of Public Health
Role Name Email Phone Street address
Principal Investigator Ali Sie sieali@crsn-nouna.bf +22620537043 Rue Namory Keita
City Postal code Country Position/Affiliation
Nouna Burkina Faso Nouna Health Research Center
Role Name Email Phone Street address
Principal Investigator Ayoade Oduola amjoduola@hotmail.com +2348034919002 Oduduwa Road, 200132
City Postal code Country Position/Affiliation
Ibadan Nigeria University of Ibadan Research Foundation
Role Name Email Phone Street address
Principal Investigator Mosa Moshabela moshabela@ukzn.ac.za +27312601736 Private Bag X54001
City Postal code Country Position/Affiliation
Durban South Africa University of KwaZulu Natal College of Health Sciences
Role Name Email Phone Street address
Principal Investigator Azan Nyundo azan.nyundo@udom.ac.tz +255262310003 1 Benjamin Mkapa Road
City Postal code Country Position/Affiliation
Dodoma United Republic of Tanzania University of Dodoma
Role Name Email Phone Street address
Principal Investigator Michael Laxy michael.laxy@tum.de +4989289249 Georg Brauchle Ring 60/62
City Postal code Country Position/Affiliation
Munich 80992 Germany Technical University of Munich
Role Name Email Phone Street address
Principal Investigator Till Baernighausen till.baernighausen@uni-heidelberg.de +496221565637 Im Neuenheimer Feld 130.3
City Postal code Country Position/Affiliation
Heidelberg 69120 Germany Heidelberg Institute of Global Health
Role Name Email Phone Street address
Principal Investigator Wafaie Fawzi mina@hsph.harvard.edu +16174321232 677 Huntington Avenue
City Postal code Country Position/Affiliation
Boston 02115 United States of America Harvard T.H. School of Public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data from the DASH cohort study, including those from this randomized trial, without any information that could be used to identify a particular individual, will be made available upon reasonable request. Informed Consent Form,Study Protocol The study protocol was finalized before the trial began and can be found here: https://osf.io/qabyx/ Data will be made available after the completion of the study. Data will be made available upon reasonable request to the Africa Academy for Public Health. As the DASH cohort study commences and data become available, this process will be described on the DASH project website.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://dash-rhissa.org/ No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information