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

11. mars 2020 oppdatert av: Keshni Arthur, University of Witwatersrand, South Africa

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

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.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

852

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Gauteng
      • Westonaria, Gauteng, Sør-Afrika, 1779
        • Kamogelo Primary school
      • Westonaria, Gauteng, Sør-Afrika, 1779
        • Westonaria primary school
      • Westonaria, Gauteng, Sør-Afrika, 1780
        • Westonaria primary mine school
      • Westonaria, Gauteng, Sør-Afrika, 1787
        • Zuurbekom Primary School
      • Westonaria, Gauteng, Sør-Afrika, 5670
        • Izanokhanyo Primary school

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

9 år til 14 år (Barn)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

Inclusion Criteria:

-

Exclusion Criteria:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
HIV/AIDS-related knowledge, attitude, behaviour, practices and skills
Tidsramme: 3 months
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
Tidsramme: 3 months
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
Tidsramme: 3 months
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
Tidsramme: 3 months
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
Tidsramme: 3 months
The primary outcome was the effects and differences between the student, pretest and posttest, and the parent, pretest and posttest.
3 months

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Gill Nelson, PHD, University of the Witwatersrand, South Africa
  • Studieleder: Nicola Christofides, PHD, University of the Witwatersrand, South Africa

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2018

Primær fullføring (Faktiske)

30. juni 2018

Studiet fullført (Faktiske)

30. juni 2018

Datoer for studieregistrering

Først innsendt

11. mars 2020

Først innsendt som oppfylte QC-kriteriene

11. mars 2020

Først lagt ut (Faktiske)

13. mars 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • UWitwatersrand

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data for all primary and secondary outcome measures will be made available.

IPD-delingstidsramme

Data has already been made available.

IPD-deling Støtteinformasjonstype

  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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