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.: PACTR202204883917313 Date of Approval: 05/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Informed Health Choices
Official scientific title Effect of the Informed Health Choices secondary school intervention on the ability of lower secondary students in Kenya to think critically about health information and choices: Protocol for a cluster-randomized trial
Brief summary describing the background and objectives of the trial There is an overabundance of claims about the advantages and disadvantages of health interventions. Many people are unable to assess the reliability of these claims. People making poor choices by acting on unreliable health claims or failing to act on reliable advice suffer consequences including waste of resources. There is a global focus on teaching critical thinking and it’s in the new Kenyan curriculum, but critical thinking about health or in general often isn’t taught in Kenyan schools. The study planned for in this protocol seeks to evaluate the effects of an education Informed Health Choices secondary school intervention on the ability of lower secondary school students in Kenya to think critically about health information and choices. The intervention consists of providing teachers with digital teaching re-sources and training in the use of resources, which will guide them through teaching 10 lessons to students. The intervention covers nine concepts from the Informed Health Choices Key Concepts framework.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Education intervention
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 27/04/2022
Actual trial start date 02/05/2022
Anticipated date of last follow up 27/04/2023
Actual Last follow-up date 20/06/2022
Anticipated target sample size (number of participants) 4000
Actual target sample size (number of participants) 4000
Recruitment status Not yet recruiting
Publication URL https://pactr.samrc.ac.za/Researcher/TrialRegister.aspx
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program 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
Control Group Kenyan standard lower secondary school curriculum Normal school timetable for 3 months 3 months Standard Kenya secondary school curriculum for form one students. Students in this level take 12 subjects each taught 40 minutes per week. 2000 Uncontrolled
Experimental Group Teaching critical thinking about health using the Informed Health Choices secondary school resources Each lesson is intended to take a single period (40 minutes) per week. But the teacher is free to see how to fit the lessons into the regular timetable. 3 months The ‘Informed Health Choices secondary school resources’ cover nine IHC Key Concepts. Classes at schools randomized to the intervention arm will be asked to complete the lesson goals in a single term (10-13 weeks). Each lesson is intended to take a single period (40 minutes) per week. Teachers are free to decide how to fit the 10 lessons into the regular school timetable or create time outside the timetable to complete the lessons. 2000
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Schools that follow national curriculum for secondary school education in Kenya Schools that have electricity Schools that consent to participate Form one teachers selected by the principal Teachers that have a smartphone or/ laptops computer Teachers that teach any one subject related to health-related or critical thinking subjects: (home science, biology, physical education, English, or Business studies) Form one students Schools that participated in the user testing or and piloting of the learning IHC resources Special needs schools International schools Schools located in sub-counties (districts) prone to floods and insecurity Adolescent: 13 Year-18 Year 13 Year(s) 15 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 23/03/2022 Masinde Muliro University of Science and Technology IERC
Ethics Committee Address
Street address City Postal code Country
910 Kakamega 50100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure is the difference between the intervention and control schools in the proportion of children with a passing score. Secondary outcome measures are: At the end of the school term - 3months, after completing the teaching of 10 Informed Health Choices lessons
Secondary Outcome • The mean difference in scores • The difference in the proportion of students with a score that indicates mastery of the nine Key Concepts. • The difference in the proportion of students that answer both questions correctly for each Key Concept • The difference in students’ intended behaviours and self-efficacy. • potential beneficial and adverse effects of the IHC digital learning resources secondary school intervention among students. • The difference in the proportion of teachers with a passing score and the first two secondary outcomes (the average score and the proportion of teachers with a score that indicates mastery of the nine Key Concepts). • The difference in scores on academic achievement measured using national examinations and end of term examination Post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tropical Intitute of community Health and Development TICH 4074 Kisumu 40103 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Norwegian Research Council Drammensveien 288 0283 Oslo Oslo NO-1327 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Andrew Andy Oxman 0213 Oslo 222 Norway University
Secondary Sponsor Margaret Kaseje 4074 Kisumu 100103 Kenya University
COLLABORATORS
Name Street address City Postal code Country
University of Rwanda 23V7 Kigali 4285 Rwanda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Faith Chesire faithchelagat@gmail.com +254721576525 4074
City Postal code Country Position/Affiliation
Kisumu 100103 Kenya PhD fellow
Role Name Email Phone Street address
Public Enquiries Margaret Kaseje mkaseje@gmail.com +254715021955 4074
City Postal code Country Position/Affiliation
Kisumu 100103 Kenya Supervisor
Role Name Email Phone Street address
Scientific Enquiries Andrew David Oxman oxman@online.no +4748254924 0213
City Postal code Country Position/Affiliation
Oslo 222 Norway Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide access to individual participant data upon request to the principal investigator. Study Protocol We will share Individual Participant Data 2 years from now (2024). The de-identified data for the trial will be made public upon request to the principal investigator
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