- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307966
Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity
March 11, 2020 updated by: Keshni Arthur, University of Witwatersrand, South Africa
Addressing the Double Burden of Diseases Through a Pre-adolescent Transdisciplinary Intervention for Inter-generational Outcomes
The study evaluates an intervention, The CIrCLE of Life Initiative, which was developed to address HIV and obesity prevention.
We evaluated whether the combined HIV and obesity intervention increased knowledge, enhanced skills, and/or promoted healthy behaviour among pre-adolescent students (9-12 years old) and their parents.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The CIrCLE of Life Initiative had both a school and home component, each comprising a learning curriculum, environmental support, and activity-based constituents that aimed to increase student knowledge and skills, and to engage parents.
Trained educators delivered lessons about HIV and obesity to all Grade 6 students at 5 government-run schools.
The classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons.
Students were asked to communicate their learnings to their parents at home.
Parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content.
The workbook contained shared student-parent homework activities that took approximately 30 minutes per week.
Study Type
Observational
Enrollment (Actual)
852
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gauteng
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Westonaria, Gauteng, South Africa, 1779
- Kamogelo Primary school
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Westonaria, Gauteng, South Africa, 1779
- Westonaria primary school
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Westonaria, Gauteng, South Africa, 1780
- Westonaria primary mine school
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Westonaria, Gauteng, South Africa, 1787
- Zuurbekom Primary School
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Westonaria, Gauteng, South Africa, 5670
- Izanokhanyo Primary school
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 14 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All Grade 6 learners and their parents from 5 government-run primary schools
Description
Inclusion Criteria:
-
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intervention
537 pre-adolescent grade 6 learners and their parent (n=537) were invited to participate.
Trained educators delivered lessons about HIV and obesity to all Grade 6 students at 5 government-run schools.
The classroom curriculum for students required delivery of a five-hour face-to-face intervention delivered weekly through 10 30-minute lessons.
Students were asked to communicate their learnings to their parents at home.
Parents were requested to read through the lesson in a workbook and to sign acknowledgement that they had read the content.
The workbook contained shared student-parent homework activities that took approximately 30 minutes per week.
Data was only collected from Learners (n=425) and parents (n= 427)who had consented to the study.
A pretest was conducted.
The intervention was then implemented.
A posttest was conducted afterwards.
Both parents and learners answered self-reported questionnaires.
|
HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV/AIDS-related knowledge, attitude, behaviour, practices and skills
Time Frame: 3 months
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The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
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3 months
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obesity-related awareness, attitude and skills
Time Frame: 3 months
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The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
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3 months
|
nutrition-related awareness, attitude, behaviour and skills
Time Frame: 3 months
|
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
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3 months
|
physical activity-related awareness, attitude, behaviour and skills
Time Frame: 3 months
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The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
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3 months
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child-parent communication
Time Frame: 3 months
|
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pre-adolescent parent inter-generational knowledge transfer
Time Frame: 3 months
|
The second outcome determined whether the intervention, delivered to students, could influence knowledge transfer and translation in parents.
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Gill Nelson, PHD, University of the Witwatersrand, South Africa
- Study Director: Nicola Christofides, PHD, University of the Witwatersrand, South Africa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
March 11, 2020
First Submitted That Met QC Criteria
March 11, 2020
First Posted (Actual)
March 13, 2020
Study Record Updates
Last Update Posted (Actual)
March 13, 2020
Last Update Submitted That Met QC Criteria
March 11, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UWitwatersrand
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data has already been made available.
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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