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.: PACTR201706002224335 Date of Approval: 22/04/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ibadan Active Kids Project (IBAKP)
Official scientific title EFFECTS OF A MULTI-LEVEL INTERVENTION ON THE PATTERN OF PHYSICAL ACTIVITY AMONG IN-SCHOOL ADOLESCENTS IN OYO STATE, NIGERIA
Brief summary describing the background and objectives of the trial Physical inactivity contributes to the global burden of non communicable diseases (NCDs). Sedentary behaviours in the early years could influence the development of diseases later in life. Studies on physical activity (PA) in Nigeria have focused largely on individual behaviours; none have assessed the effectiveness of school-based interventions in promoting PA in children and adolescents. The aim of the proposed study is to identify factors influencing; and evaluate the effects of a multi level intervention on the PA behaviours of in-school adolescents in Oyo state, south western Nigeria. The study will adopt a quasi- experimental design guided by the socio-ecological model and theory of reasoned action. Baseline data will be obtained through a mixed methods approach comprising a cross sectional survey to document the self-reported PA levels coupled with objectively measured PA levels using pedometers for a subset of the sample. The association between behavioural factors (attitude, perceived behavioural control, self efficacy, subjective norms, social support from friends, family and teachers) and physical activity levels will be assessed. Other measurements including weight, height, waist and hip circumferences, fitness level using the 20-m shuttle run test (20-mSRT) and blood pressure will be obtained. The schools¿ built environment and policy support for physical activity will be assessed coupled with key informant and focus group discussions with the school authorities. Baseline findings will guide the design and implementation of a 2-week multi level intervention. The primary outcome measures are self¿reported and 7-day objectively measured physical activity. Other secondary outcome measures such as, body mass index for age, waist-to-hip ratio, physical fitness, blood pressure will be obtained. Follow-up measurements will be taken immediately and 3- months post after the intervention.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) IBAKP
Disease(s) or condition(s) being studied Paediatrics,Physical Inactivity
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/03/2016
Actual trial start date 01/03/2016
Anticipated date of last follow up 03/07/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 1200
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as balloting and systematic sampling technique Allocation was determined by the use of the class register using a systematic sampling approach Open-label(Masking Not Used)
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as balloting and systematic sampling technique Allocation was determined by the use of the class register using a systematic sampling approach Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multi level intervention Weekly 12 weeks Multi-level intervention:(1)Policy and consultative meetings with School principals/heads and Officials of the Ministry of Health (2) Health Awareness Talk with School Teachers on Non-communicable Diseases and Physical Activity and Meidcal Assessment for Obesity and Hypertension (3) Educational Materials production and distribution and training sessions for students on physical activity for health 60
Control Group control arm (no intervention) No intervention, usual practice of physical health education in school 12 weeks No intervention, usual practice of physical health education in school 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
In-school adolescents in public and private single sex and co-educational schools Out of school youths In-school adolescents in schools for the disabled In school adolescents with other health conditions which prevents them from engaging in vigorous physical activity 10 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 01/06/2015 Research Ethical Review Commiittee, Ministry of Health, Oyo State
Ethics Committee Address
Street address City Postal code Country
Secretariat Road, Oyo State Ibadan 5027 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self¿reported physical activity levels and 7-day objectively measured physical activity levels Timepoint 1-Baseline (0 week) Timepoint 2: Immediately after the 12 week intervention (12 weeks) Timepoint 3: 3 months after the intervention (24 weeks)
Secondary Outcome body mass index for age, waist-to-hip ratio, physical fitness, blood pressure Timepoint 1-Baseline (0 week) Timepoint 2: Immediately after the 12 week intervention (12 weeks) Timepoint 3: 3 months after the intervention (24 weeks)
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Health Promotion and Education, Faculty of Public HealthUniversity of Ibadan UCH Campus, Queen Elizabeth Road, Mokola Ibadan Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
African Population Health Research Center APHRC Campus, 2nd Floor; Manga Close, Off Kirawa Road; Nairobi P.O. Box 10787-0010 Kenya
Center for Global Health, University of Chicago Chicago United States of America
Center for Population and Reproductive Health, University of Ibadan Ibadan Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Health Promotion and Education, Faculty of Public Health, College of Medicine, Unviersity of Ibadan Queen Elizabeth Road, Mokola Ibadan Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Mojisola Oluwasanu Department of Health Promotion and Education, Faculty of Public Health, College of Medicine, Unviersity of Ibadan Ibadan Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mojisola Oluwasanu ope3m@yahoo.com +2347087957406 Department of Health Promotion and Education, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Segun Ibitoye segunmanuelgcfr@yahoo.com +2348135567066 Department of Health Promotion and Education, University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Intern
Role Name Email Phone Street address
Public Enquiries Mojisola Oluwasanu ope3m@yahoo.com 11
City Postal code Country Position/Affiliation
Ibadan Nigeria
Role Name Email Phone Street address
Scientific Enquiries Mojisola Oluwasanu ope3m@yahoo.com +2347087957406 Department of Health Promotion and Education, Unviersity of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Lecturer
REPORTING
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