HivNCT04307966
Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity
An observational study of Hiv and Obesity, run by University of Witwatersrand, South Africa at 5 sites in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 9 to 14 years
- What is being tested?
- The CIrCLE of Life Initiative
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 852 participants
- Where
- 5 sitesSouth Africa
- Study dates
- 1 May 2018to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Child
Study population: All Grade 6 learners and their parents from 5 government-run primary schools
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Africa5 sites
Kamogelo Primary school
Westonaria, Gauteng, 1779
Westonaria primary school
Westonaria, Gauteng, 1779
Westonaria primary mine school
Westonaria, Gauteng, 1780
Zuurbekom Primary School
Westonaria, Gauteng, 1787
Izanokhanyo Primary school
Westonaria, Gauteng, 5670
About this study
Official title: 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.
Read the 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.
- Being tested
- The CIrCLE of Life Initiative
- Keywords
- inter-generational outcomes, Pre-adolescents
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The CIrCLE of Life InitiativeBehavioural
HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: The CIrCLE of Life Initiative |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV/AIDS-related knowledge, attitude, behaviour, practices and skills
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
Measured: 3 months
obesity-related awareness, attitude and skills
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
Measured: 3 months
nutrition-related awareness, attitude, behaviour and skills
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
Measured: 3 months
physical activity-related awareness, attitude, behaviour and skills
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
Measured: 3 months
child-parent communication
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
Measured: 3 months
Secondary outcomes (1)
pre-adolescent parent inter-generational knowledge transfer
The second outcome determined whether the intervention, delivered to students, could influence knowledge transfer and translation in parents.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start1 May 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty Clinical Research Inc., National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Keshni Arthur, University of Witwatersrand, South Africa
- Investigators
- Gill Nelson, PHD, Study director, University of Witwatersrand, South AfricaNicola Christofides, PHD, Study director, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307966
- Sponsor's protocol ID
- UWitwatersrand
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Arthur K, Christofides N, Nelson G. Effectiveness of a pre-adolescent inter-generational intervention to address HIV and obesity in South Africa, using a pretest-posttest design. BMC Public Health. 2021 Dec 11;21(1):2251. doi: 10.1186/s12889-021-12228-z.
PubMed 34895196
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Double Burden of Diseases Through a Pre-adolescent Transdisciplinary Intervention for Inter-generational Outcomes
- ClinicalTrials.gov ID
- NCT04307966
- Acronym / sponsor ID
- UWitwatersrand
- Keywords
- inter-generational outcomes, Pre-adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Collaborators
- Fogarty Clinical Research Inc., National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina, Chapel Hill
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Behavioral: The CIrCLE of Life Initiative537 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- All Grade 6 learners and their parents from 5 government-run primary schools
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The CIrCLE of Life InitiativeHIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents. | Behavioural | Intervention |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
pre-adolescent parent inter-generational knowledge transfer
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Derived from this study: PubMed 34895196Arthur K, Christofides N, Nelson G. Effectiveness of a pre-adolescent inter-generational intervention to address HIV and obesity in South Africa, using a pretest-posttest design. BMC Public Health. 2021 Dec 11;21(1):2251. doi: 10.1186/s12889-021-12228-z.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
Related trials for Hiv
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gill Nelson, PHD study director
University of Witwatersrand, South Africa
Nicola Christofides, PHD study director
University of Witwatersrand, South Africa
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hiv and Obesity, run by University of Witwatersrand, South Africa at 5 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV/AIDS-related knowledge, attitude, behaviour, practices and skills (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04307966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.