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.: PACTR202005750708479 Date of Approval: 08/05/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of selling fruits in pieces or in bulk in improving fruit consumption of high-school students: A cluster randomized controlled trial in urban Ethiopia
Official scientific title Effectiveness of selling fruits in pieces or in bulk in improving fruit consumption of high-school students: A cluster randomized controlled trial in urban Ethiopia
Brief summary describing the background and objectives of the trial Diets high in fruits and vegetables are widely recommended for healthier life. However, fruit consumption in Ethiopia is very low. The barriers and enablers affecting consumer behavior towards fruits consumption including price, preference, quality, safety and access are largely undocumented. For example, fruits are sold around some schools, but the minimum amount that one can buy is half a kilogram. This may discourage students from buying fruits as a snack. Therefore, the objective of this study was to evaluate whether selling fruits in pieces improves consumption and volume of sale than the current practice of selling fruits in bulk (kilogram).
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 Physical activity and nutrition
Anticipated trial start date 04/02/2019
Actual trial start date 04/02/2019
Anticipated date of last follow up 14/06/2019
Actual Last follow-up date 14/06/2019
Anticipated target sample size (number of participants) 360
Actual target sample size (number of participants) 330
Recruitment status Completed
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Selling fruit in bulk or in kilograms Around the control school, the sellers were allowed only to sale in bulk (in kilograms). For 5 month and 10 days In the intervention group, fruits were sold in piece. The seller will be told to only sell in piece. Before intervention starts, the sellers were trained to advertise their mobile shop that they only sell in piece. They also labeled the price of each single fruit as advertisement. 2 Active-Treatment of Control Group
Experimental Group Selling fruit in peices Five working days a week during school hour 5 month and 10 days In the intervention group, fruits were sold in piece. The seller will be told to only sell in piece. Before intervention starts, the sellers were trained to advertise their mobile shop that they only sell in piece. They also labeled the price of each single fruit as advertisement. 2
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Randomly selected high school adolescents who were 19 years or less Students who were above the age requirement Students who were transferred to the school with in 3 months before the study Adolescent: 13 Year-18 Year 13 Year(s) 19 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 04/04/2019 College of natural and computational science institutional review board
Ethics Committee Address
Street address City Postal code Country
4 killo Addis Ababa 1176 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fruit consumption among high school adolescents expressed in fruit consumption score At the beginning and every 50 days after the intervention started
Secondary Outcome Volume of sale measured at the end of each day Every day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Center of food science and nutrition 4 killo Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wageningen university and research Droevendaalsesteeg 4, 6708 PB Wageningen Gelderland 6700 Netherlands
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University 4 Killo Addis Ababa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bereket Gebremichael bdpapi3@gmail.com +251912660125 Eritiria Street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Assistant professor
Role Name Email Phone Street address
Public Enquiries Kaleab Baye kaleabbaye@gmail.com +251911890489 4 killo
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Associate professor
Role Name Email Phone Street address
Scientific Enquiries Demewoz Haile demozahn@gmail.com +251911992102 4 killo
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia PhD candidate
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available up on reasonable request to the corresponding author. All individual participant data will be available after deidentification. Study protocol will also be available. To researchers who provide methodologically sound proposal directed to the principal investigator Bereket Gebremichael via email bdpapi3@gmail.com immediately following publication. Study Protocol Immediately after publication To researchers who provide methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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