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

NCT04307966 | Completed DMC

• 1 other identifier: UWitwatersrand
• Study Type: observational
• Target: 852
• Locations: 1 country
• Sites: 5

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.

Conditions

Hiv; Obesity

Keywords

inter-generational outcomes; Pre-adolescents

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• pre-adolescent parent inter-generational knowledge transfer

  3 months

Study Arms (1)

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.

Behavioral: The CIrCLE of Life Initiative

Interventions

The CIrCLE of Life Initiative BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All Grade 6 learners and their parents from 5 government-run primary schools

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead
• Fogarty Clinical Research Inc.: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (5)

Kamogelo Primary school

Westonaria, Gauteng, 1779, South Africa

Location

Westonaria primary school

Westonaria, Gauteng, 1779, South Africa

Location

Westonaria primary mine school

Westonaria, Gauteng, 1780, South Africa

Location

Zuurbekom Primary School

Westonaria, Gauteng, 1787, South Africa

Location

Izanokhanyo Primary school

Westonaria, Gauteng, 5670, South Africa

Location

Related Publications (1)

• 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.

  PMID: 34895196 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Obesity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gill Nelson, PHD

  University of the Witwatersrand, South Africa

  STUDY DIRECTOR

• Nicola Christofides, PHD

  University of the Witwatersrand, South Africa

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mrs

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 13, 2020
• Study Start: May 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data has already been made available.

Locations

ZA (5)