Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity

NCT ID: NCT04307966

Last Updated: 2020-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

852 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hiv Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

The CIrCLE of Life Initiative

Intervention Type BEHAVIORAL

HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The CIrCLE of Life Initiative

HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fogarty Clinical Research Inc.

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

University of Witwatersrand, South Africa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Keshni Arthur

Mrs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gill Nelson, PHD

Role: STUDY_DIRECTOR

University of the Witwatersrand, South Africa

Nicola Christofides, PHD

Role: STUDY_DIRECTOR

University of the Witwatersrand, South Africa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kamogelo Primary school

Westonaria, Gauteng, South Africa

Site Status

Westonaria primary school

Westonaria, Gauteng, South Africa

Site Status

Westonaria primary mine school

Westonaria, Gauteng, South Africa

Site Status

Zuurbekom Primary School

Westonaria, Gauteng, South Africa

Site Status

Izanokhanyo Primary school

Westonaria, Gauteng, South Africa

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Africa

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34895196 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UWitwatersrand

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Life Plans Intervention Study
NCT03215901 COMPLETED NA