Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Evaluation of a Multiple Behaviour Programme for Diarrhoea Management

10. marts 2016 opdateret af: London School of Hygiene and Tropical Medicine

Evaluation of a Multiple Behaviour Programme to Prevent and Manage Diarrhoea Among Children Under-five in Lusaka, Zambia

Control of diarrhoeal disease requires a comprehensive package of preventive and curative interventions. in Zambia, the Programme for Awareness and Elimination of Diarrhoea (PAED) aims to reduce child deaths by combating diarrhoea in Lusaka province, Zambia. The behaviour change component of the PAED programme seeks to change behaviours important for diarrhoea prevention (handwashing with soap and exclusive breastfeeding) and improved treatment outcomes (use of oral rehydration solution (ORS) and zinc in home management of child diarrhoea).

The study aims to evaluate the feasibility of implementing a multiple behaviour change community programme to tackle diarrhoeal disease in children under-five and to assess the impact of this programme on practice of the target behaviours by caregivers of children under-five. The research questions will be answered through a a two-arm cluster-randomised trial (eight clusters per study arm).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Specific objectives of the study are as follows:

  • Evaluate the effect of the programme on ORS and zinc uptake and usage, exclusive breastfeeding and handwashing with soap (primary objective)
  • Determine the extent to which the programme has positively influenced key mediating factors that determine behaviour (i.e. social norms, physical infrastructure, attitudes, and disease and treatment perceptions)

  • Investigate which components of the community programme (i.e. specific activities in clinics, community events etc.) are linked to the success of the programme (most acceptable, feasible etc) and in what context

    o Validate model of intervention theory that explains how the context and mechanisms of the intervention interact to produce behavioural outcomes

  • Determine which target populations are more likely to uptake the desired behaviours and identify the supporting factors that might explain this
  • Conduct process evaluation to assess i) if the programme has been implemented as intended, ii) if the desired levels of reach and coverage have been achieved, iii) costs of implementation, iv) the extent to which changes in behaviour are likely to be due to the intervention.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

640

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Zambia
    • Lusaka Province
      • Lusaka, Lusaka Province, Zambia
        • Centre for Infectious Disease Research Zambia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 måned til 4 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • caregiver with child under six months (for assessment of handwashing and exclusive breastfeeding outcomes - healthy volunteers)
  • caregiver with child under five years with current or recent (last 7 days) diarrhoea (for assessment of ORS and zinc outcomes)

Exclusion Criteria:

  • Not resident in study area

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Community behaviour change campaign
Participants will be exposed to the community behaviour change intervention.
Adfærdsmæssigt: Community behaviour change campaign
Community campaign targeting exclusive breastfeeding, handwashing with soap, and use of ORS and zinc to manage child diarrhoea. Includes a range of activities within the community (large events and small group sessions); clinic activities (ORS preparation), radio adverts.
Ingen indgriben: No community behaviour change campaign
No community intervention will take place in the control arm, although exposure to some intervention messaging (radio adverts) may take place.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in target behaviour: zinc use
Tidsramme: six weeks post-intervention

Proportion of under-five diarrhoeal episodes receiving zinc.

The study aims to demonstrate the intervention can successfully change behaviour and therefore no health outcomes were chosen and there is a primary outcome for each behaviour.
six weeks post-intervention
Change in target behaviour: correct ORS preparation
Tidsramme: six weeks post-intervention
Proportion of caregivers able to demonstrate correct ORS preparation.
six weeks post-intervention
Change in target behaviour: Exclusive breastfeeding
Tidsramme: six weeks post-intervention
Proportion of mothers exclusively breastfeeding infants 0-5 months of age.
six weeks post-intervention
Change in target behaviour: Handwashing with soap
Tidsramme: six weeks post-intervention
Proportion of observed handwashing events where there is risk of faecal contamination (i.e. after latrine and when dealing with child stools) accompanied by handwashing with soap
six weeks post-intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in target behaviours: ORS use
Tidsramme: six weeks post-intervention
Proportion of under-five diarrhoeal episodes receiving ORS.
six weeks post-intervention
Change in target behaviours: ORS storage
Tidsramme: six weeks post-intervention
Proportion of caregivers storing ORS sachets at home
six weeks post-intervention
Change in target behaviours: zinc trial
Tidsramme: six weeks post-intervention
Proportion of caregivers of a child under-five who have ever used zinc to treat diarrhoea in a child
six weeks post-intervention
Zinc awareness
Tidsramme: six weeks post-intervention
Proportion of caregivers who have heard of zinc for diarrhoea treatment
six weeks post-intervention
Change in target behaviours: exclusive breastfeeding 0-2 months
Tidsramme: six weeks post-intervention
Proportion of mothers exclusively breastfeeding infants 0-2 months of age.
six weeks post-intervention
Change in target behaviours: predominant breastfeeding
Tidsramme: six weeks post-intervention
Proportion of mothers predominantly breastfeeding infants 0-5 months of age.
six weeks post-intervention
Change in target behaviours: handwashing with soap at key times
Tidsramme: six weeks post-intervention
Proportion of observed handwashing events associated with food handling or faeces accompanied by handwashing with soap
six weeks post-intervention
Change in target behaviours: use of soap
Tidsramme: six weeks post-intervention
Proportion of observed handwashing occasions where soap is used
six weeks post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

London School of Hygiene and Tropical Medicine

Samarbejdspartnere

Centre for Infectious Disease Research in Zambia
Absolute Return for Kids

Efterforskere

  • Ledende efterforsker: Roma Chilengi, Centre for Infectious Disease Research in Zambia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2014

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. november 2014

Datoer for studieregistrering

Først indsendt

5. marts 2014

Først indsendt, der opfyldte QC-kriterier

5. marts 2014

Først opslået (Skøn)

7. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. marts 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2016

Sidst verificeret

1. marts 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • QA511

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner