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

Completed

• Conditions: Hiv; Obesity
• Interventions: Behavioral: The CIrCLE of Life Initiative

• Registration Number: NCT04307966
• Lead Sponsor: University of Witwatersrand, South Africa

Brief 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 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 Timeline

• Study Start: 2018-05-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2020-03
• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-11
• Last Update Submitted: 2020-03-11
• Study First Posted: 2020-03-13
• Last Update Posted: 2020-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 852

Inclusion Criteria

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention	The CIrCLE of Life Initiative	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.

Primary Outcome Measures

Name	Time	Method
HIV/AIDS-related knowledge, attitude, behaviour, practices and skills	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	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	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	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	3 months	The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.

Secondary Outcome Measures

Name	Time	Method
pre-adolescent parent inter-generational knowledge transfer	3 months	The second outcome determined whether the intervention, delivered to students, could influence knowledge transfer and translation in parents.

Trial Locations

Locations (5)

Kamogelo Primary school; 🇿🇦 Westonaria, Gauteng, South Africa

Westonaria primary school; 🇿🇦 Westonaria, Gauteng, South Africa

Westonaria primary mine school; 🇿🇦 Westonaria, Gauteng, South Africa

Zuurbekom Primary School; 🇿🇦 Westonaria, Gauteng, South Africa

Izanokhanyo Primary school; 🇿🇦 Westonaria, Gauteng, South Africa