- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04307966
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
Intervensjon / Behandling
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.
Samarbeidspartnere
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
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
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