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.: PACTR201709002540178 Date of Approval: 22/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF BEHAVIORAL MODIFICATION INTERVENTION TO REDUCE CARDIOVASCULAR DISEASE RISK FACTORS AMONGST PUBLIC SECONDARY SCHOOL STUDENTS IN BRONG
Official scientific title EFFECTIVENESS OF BEHAVIORAL MODIFICATION INTERVENTION TO REDUCE CARDIOVASCULAR DISEASE RISK FACTORS AMONGST PUBLIC SECONDARY SCHOOL STUDENTS IN BRONG AHAFO, GHANA
Brief summary describing the background and objectives of the trial Cardiovascular disease (CVD) is the leading cause of death globally. Risk factors for coronary artery disease and stroke begin in childhood. A randomised controlled field trial with single blinding will be conducted to develop, implement, and evaluate the effectiveness of a school based intervention on behavioral risk factors of CVDs amongst public secondary school stuedents in Brong Ahafo Region, Ghana. A cluster randomised sampling will be used to select 4 (which will be, 2 intervention schools and 2 control schools) schools in Brong Ahafo Region, Ghana. The CVD risk factor intervention module will then be developed, implemented, and evaluated based on the Information-Motivation-Behavioral Skills theory in the intervention group for a period of six months. The comprehensive and interactive intervention program will consist of lectures, sports, and videos. The study will have a sample size of 848 students. A validated and reliable structured questionnaire will be used to obtain the necessary information before (baseline) and after 6 months of intervention (post intervention). The structured questionnaire will be divided mainly into three sections which are (a) socio-demographic factors, (b) CVD risk factors including unhealthy diet, smoking, physical inactivity, alcohol intake, obesity and blood pressure, and (c) CVD knowledge, motivation, and behavioral skills. Descriptive and multivariate statistics will be used to analyse the data with IBM SPSS version 22. Test of significance will be at ¿ level 0.05. This study is expected to improve behavioral changes such as CVD knowledge, motivation, behavioral skills, increased physical activity, consumption of healthy foods, reduced smoking, and alcohol consumption habits of secondary school children. The students are also expected at the end of the study to transfer the knowledge gained to their home and peers.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Cardiovascular Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/10/2017
Actual trial start date 02/10/2017
Anticipated date of last follow up 20/08/2018
Actual Last follow-up date 20/08/2018
Anticipated target sample size (number of participants) 848
Actual target sample size (number of participants) 848
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 Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Disease Prevention 6 months Normal school curricula 424 Placebo
Experimental Group Disease Prevention 2 times a week 6 months Consist of theoretical sessions, videos, physical activies, and discussions 424
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All public secondary school students from form 1, 2 and 3 in four districts that will be selected for the study. Students who are physically challenged such as students on wheelchair and cannot accurately measure body weight and height or are suffering from serious medical conditions such as heart diseases, asthma or respiratory conditions or as advised by a medical professional to restrict physical activities/exercise. 14 Year(s) 18 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 09/06/2017 University Putra Malaysia Ethic Committee Involving Human Subjects (JKEUPM)
Ethics Committee Address
Street address City Postal code Country
43400 UPM Serdang Serdang Malaysia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome increase knowledge in CVD and thereby improve behavioral changes such as increased physical activity, consumption of healthy foods, reduced smoking and alcohol consumption habits Increase knowledge in cardiovascular disease(CVD) - 6 months Improve behavioral changes such as increased physical activity, consumption of healthy foods, reduced smoking and alcohol consumption habits - 6 months
Secondary Outcome Obesity (BMI) and hypertension (Systolic and Diastolic blood pressures) Obesity - 6 months Hypertension - 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Public Secondary Schools High Street Kintampo 200 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Government of Ghana 42nd 4th Close Airport Residential Area Accra Ghana Accra PMB 254 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kintampo Health Research Centre KHRC High Street Kintampo 200 Ghana Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
University Putra Malaysia 43400 UPM Serdang Serdang Malaysia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator John Amoah johnny_amoah@yahoo.com +233208209847 KHRC High Street
City Postal code Country Position/Affiliation
Kintampo Ghana Research Fellow/Kintampo Health Research Centre
Role Name Email Phone Street address
Public Enquiries Seth Owusu-Agyei seth.owusu-agyei@kintampo-hrc.org +233244560213 KHRC High Street
City Postal code Country Position/Affiliation
Kintampo Ghana Director, Institute of Health Research, University of Health and Allied Sciences
Role Name Email Phone Street address
Scientific Enquiries Salmiah Binti Md. Said salmiahms@medic.upm.edu.my +60136362574 43400 UPM Serdang
City Postal code Country Position/Affiliation
Serdang Malaysia Senior Lecturer (Medical), Faculty of Medicine and Health Sciences, University Putra, Malaysia
REPORTING
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