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.: PACTR201412000926216 Date of Approval: 04/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title evaluation of the lifestyle intervention
Official scientific title An evaluation of the effects of a lifestyle intervention on eating and physical activity behaviours of urban adolescents in junior public secondary schools in Botswana: a pragmatic randomized controlled trial pilot study
Brief summary describing the background and objectives of the trial There is a vast body of published data to indicate that, over the past decade the prevalence of overweight among adolescents worldwide has escalated. Due to urbanization in Botswana overweight is also suspected to have increased over the past decade. In Botswana overweight prevalence among adolescents in urban and rural secondary schools is reportedly 27.1% (192/702) in private schools and 13.1% (93/702) in public secondary schools. It is reported that School personnel, convenience store owners and students acknowledge that overweight is a problem in secondary schools in Botswana. There is no published literature from Botswana on culturally suited nutritional lifestyle intervention programs for any age groups to impact behaviour change. This implies that causes of overweight and interventions to prevent or address the problem in Botswana, particularly among adolescents, may not yet have been explored. Study One The objectives of this study are to: 1. describe respondents¿ socio-demographic characteristics; 2. determine the prevalence of overweight; 3. describe respondents ¿eating habits; 4. identify influences on food choice and preferences; 5. determine awareness and knowledge of healthy eating/food intake behaviour; 6. describe physical activity levels; 7. determine respondents¿ intentional level to change eating and physical activity behaviours; 8. determine self-efficacy level for changing eating and physical activity behaviours. Study Two The objectives of this studyare to establish whether the lifestyle intervention program results in a significant difference in: 1. improvingeatinghabits between the intervention and control group; 2. physical activity levels between the intervention and control group; 3. nutritional knowledge between the intervention and control group; 4. intention and self-efficacy for adopting a healthy lifestylebetween the intervention and control group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,prevention of Overweight
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 08/01/2016
Actual trial start date 11/01/2016
Anticipated date of last follow up 05/04/2016
Actual Last follow-up date 05/04/2016
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 46
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 1.invite all 13 junior public secondary schools in Gaborone City to participate in the study. 2. A simple random sampling method will be used to select 8 schools. Then a stratified random sampling will be used to select the required sample of students. 3. From each school, the researcher will get lists of students per stream, for example grade 8, 9 and 10 strata. From the 3 strata per school, a certain proportion of potential study subjects will be randomly selected using a computer random number generator to give each student in each stratum an equal opportunity to be selected. From the eight schools participating in Study One, four schools will be randomly selected for Study Two by an independent statistician. By randomization two schools will be allocated to the intervention trial arm and two to the control trial arm, from which a sample of pupils who had already participated in Study One will be randomly selected and invited to participate in the study. Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lifestyle intervention program once once Lifestyle intervention program will consist of nutririon education, motivation and behavioural skills information 21 Placebo
Experimental Group Lifestyle intervention program one hour weekly 8 weeks nutrition, physical activity, motivation and behavioral skills 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.males and females aged 13-15 years; 2.resident in Gaborone city; 3.who attend public junior secondary schools; 4.who assent and whose parents consent to participate in the study; 5.whether overweight or not; 6.in schools where administrators agree to participate. 1.Known pregnancy after the 3rd trimester. 2.Participants who answer yes to one or more questions about health problems in the physical activity readiness questionnaire 3.Participants with a known metabolic disorder. 4.Participants with known physical impairment or disability 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 22/09/2014 Human
Ethics Committee Address
Street address City Postal code Country
observatory, 7965 Cape Town South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. change in eating habits-reduce sugar, fat intake and increase in vegetables and fruits intake, increase in physical activities behaviors end of 8 weeks
Secondary Outcome improved nutritional knowledge, end of 8 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nanogang school gaborone village Gaborone 001 Botswana
junior secondary schools Gaborone Botswana
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Botswana Gaborone village Gaborone 001 Botswana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Botswana Gaborone village Gaborone 001 Botswana University
COLLABORATORS
Name Street address City Postal code Country
N/A N/A N/A N/A Botswana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Una Kyriacos una.kyriacos@uct.ac.za :+ 27-21-4066410 observatory 7965
City Postal code Country Position/Affiliation
cape town South Africa senior lecturer
Role Name Email Phone Street address
Public Enquiries Marc Blockman Marc.Blockman@uct.ac.za +27214066338 Room E52-24 Groote Schuur Hospital Old MainBuilding
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Associate Professor/University of Cape Town
Role Name Email Phone Street address
Scientific Enquiries Meridith Harris m.harris@neu.edu 508-477-3614 531 main street
City Postal code Country Position/Affiliation
BOSTON United States of America mellon scholar
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information