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

Obesity Clinical Trial

Official title:

Addressing the Double Burden of Diseases Through a Pre-adolescent Transdisciplinary Intervention for Inter-generational Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307966
• Other study ID #: UWitwatersrand
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2020
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 parents.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 852
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hiv
• Obesity

Intervention

Behavioral:
• The CIrCLE of Life Initiative
HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.

Locations

Country	Name	City	State
South Africa	Izanokhanyo Primary school	Westonaria	Gauteng
South Africa	Kamogelo Primary school	Westonaria	Gauteng
South Africa	Westonaria primary mine school	Westonaria	Gauteng
South Africa	Westonaria primary school	Westonaria	Gauteng
South Africa	Zuurbekom Primary School	Westonaria	Gauteng

Sponsors (4)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa	Fogarty Clinical Research Inc., National Institute of Allergy and Infectious Diseases (NIAID), University of North Carolina, Chapel Hill

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	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.	3 months
Primary	child-parent communication	The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.	3 months
Secondary	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.	3 months