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

Conditions

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

    • Gauteng
      • Westonaria, Gauteng, South Africa, 1779
        • Kamogelo Primary school
      • Westonaria, Gauteng, South Africa, 1779
        • Westonaria primary school
      • Westonaria, Gauteng, South Africa, 1780
        • Westonaria primary mine school
      • Westonaria, Gauteng, South Africa, 1787
        • Zuurbekom Primary School
      • Westonaria, Gauteng, South Africa, 5670
        • Izanokhanyo Primary school

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.

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
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
3 months
obesity-related awareness, attitude 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.
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.
3 months
physical activity-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.
3 months
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.
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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