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Completed

NCT Number: NCT04307966

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

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.

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Key information

Conditions

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

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Izanokhanyo Primary school, Westonaria, Gauteng, South Africa

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

-

Treatment and study plan

The CIrCLE of Life Initiative

Behavioral

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

Primary outcomes

  1. HIV/AIDS-related knowledge, attitude, behaviour, practices and skills

    Time frame: 3 months

    The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.

  2. obesity-related awareness, attitude and skills

    Time frame: 3 months

    The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.

  3. nutrition-related awareness, attitude, behaviour and skills

    Time frame: 3 months

    The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.

  4. physical activity-related awareness, attitude, behaviour and skills

    Time frame: 3 months

    The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.

  5. child-parent communication

    Time frame: 3 months

    The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.

Secondary outcomes

  1. pre-adolescent parent inter-generational knowledge transfer

    Time frame: 3 months

    The second outcome determined whether the intervention, delivered to students, could influence knowledge transfer and translation in parents.

Sponsors and collaborators

Lead sponsor

University of Witwatersrand, South Africa

Other

Collaborators

  • Fogarty Clinical Research Inc.
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 13, 2020
Registry last updated
Mar 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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