Main
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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:
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PACTR |
Last refreshed on:
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29 May 2023 |
Main ID: |
PACTR201412000926216 |
Date of registration:
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04/11/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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evaluation of the lifestyle intervention
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Scientific title:
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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:
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08/01/2016 |
Target sample size:
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48 |
Recruitment status: |
Complete |
URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=926 |
Study type:
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Interventional |
Study design:
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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
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Phase:
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Not Applicable
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Countries of recruitment
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Botswana
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Contacts
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Name:
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Marc
Blockman |
Address:
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Room E52-24 Groote Schuur Hospital Old MainBuilding
7925
Cape Town
South Africa |
Telephone:
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+27214066338 |
Email:
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Marc.Blockman@uct.ac.za |
Affiliation:
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Associate Professor/University of Cape Town |
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Name:
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Meridith
Harris |
Address:
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531 main street
BOSTON
United States of America |
Telephone:
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508-477-3614 |
Email:
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m.harris@neu.edu |
Affiliation:
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mellon scholar |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Nutritional, Metabolic, Endocrine prevention of Overweight
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Nutritional, Metabolic, Endocrine
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prevention of Overweight
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Intervention(s)
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Lifestyle intervention program
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Primary Outcome(s)
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1.change in eating habits-reduce sugar, fat intake and increase in vegetables and fruits intake, increase in physical activities behaviors
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Secondary Outcome(s)
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improved nutritional knowledge,
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Source(s) of Monetary Support
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University of Botswana
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Ethics review
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Status: Approved
Approval date: 22/09/2014
Contact:
Human
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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