Clinical trial NCT04307966: Effectiveness of a Pre-adolescent Inter-generational Intervention to Address HIV and Obesity
Official title: Addressing the Double Burden of Diseases Through a Pre-adolescent Transdisciplinary Intervention for Inter-generational Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hiv
Obesity
Keywords: inter-generational outcomes
Pre-adolescents
Lead sponsor: University of Witwatersrand, South Africa
Sponsor class: OTHER
Collaborators: name: Fogarty Clinical Research Inc.
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: University of North Carolina, Chapel Hill
First posted: 2020-03-13
Enrollment: 852
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Grade 6 learners and their parents from 5 government-run primary schools

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.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: HIV/AIDS-related knowledge, attitude, behaviour, practices and skills
timeFrame: 3 months
measure: obesity-related awareness, attitude and skills
timeFrame: 3 months
measure: nutrition-related awareness, attitude, behaviour and skills
timeFrame: 3 months
measure: physical activity-related awareness, attitude, behaviour and skills
timeFrame: 3 months
measure: child-parent communication
timeFrame: 3 months
Secondary outcomes:
measure: pre-adolescent parent inter-generational knowledge transfer
timeFrame: 3 months
Other outcomes:
Locations:
city: Westonaria
country: South Africa
facility: Kamogelo Primary school
state: Gauteng
city: Westonaria
country: South Africa
facility: Westonaria primary school
state: Gauteng
city: Westonaria
country: South Africa
facility: Westonaria primary mine school
state: Gauteng
city: Westonaria
country: South Africa
facility: Zuurbekom Primary School
state: Gauteng
city: Westonaria
country: South Africa
facility: Izanokhanyo Primary school
state: Gauteng
Study officials:
affiliation: University of the Witwatersrand, South Africa
name: Gill Nelson, PHD
role: STUDY_DIRECTOR
affiliation: University of the Witwatersrand, South Africa
name: Nicola Christofides, PHD
role: STUDY_DIRECTOR
References:
citation: 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.