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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: PACTR
Last refreshed on: 29 May 2023
Main ID:  PACTR201412000926216
Date of registration: 04/11/2014
Prospective Registration: Yes
Primary sponsor: University of Botswana
Public title: evaluation of the lifestyle intervention
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
Date of first enrolment: 08/01/2016
Target sample size: 48
Recruitment status: Complete
URL:  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=926
Study type:  Interventional
Study design:  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  
Phase:  Not Applicable
Countries of recruitment
Botswana
Contacts
Name: Marc    Blockman
Address:  Room E52-24 Groote Schuur Hospital Old MainBuilding 7925 Cape Town South Africa
Telephone: +27214066338
Email: Marc.Blockman@uct.ac.za
Affiliation:  Associate Professor/University of Cape Town
Name: Meridith    Harris
Address:  531 main street BOSTON United States of America
Telephone: 508-477-3614
Email: m.harris@neu.edu
Affiliation:  mellon scholar
Key inclusion & exclusion criteria
Inclusion criteria: 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.

Exclusion criteria: 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


Age minimum: 13 Year(s)
Age maximum: 15 Year(s)
Gender: Both
Health Condition(s) or Problem(s) studied

Nutritional, Metabolic, Endocrine
prevention of Overweight
Nutritional, Metabolic, Endocrine
prevention of Overweight
Intervention(s)
Lifestyle intervention program
Primary Outcome(s)
1.change in eating habits-reduce sugar, fat intake and increase in vegetables and fruits intake, increase in physical activities behaviors
Secondary Outcome(s)
improved nutritional knowledge,
Secondary ID(s)
Source(s) of Monetary Support
University of Botswana
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 22/09/2014
Contact:
Human
Results
Results available:
Date Posted:
Date Completed:
URL:
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