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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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20 June 2022 |
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Main ID: |
ISRCTN26548981 |
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Date of registration:
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15/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Health and development effectiveness of integrated home-based interventions in rural Andean communities: a randomised trial
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Scientific title:
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A 2x2 factorial 12-month randomised trial to evaluate the effectiveness of two integrated home-based interventions in environmental health and early child development for improving health and child development in children under 36 months living in rural Andean communities (IHIP-2) |
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Date of first enrolment:
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02/07/2015 |
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Target sample size:
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320 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN26548981 |
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Study type:
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Interventional |
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Study design:
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Community-level controlled 2x2 factorial cluster randomised non-blinded trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Peru
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Stella
Hartinger |
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Address:
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Av. Reynaldo de Vivanco 410, Dept 405B, Chacarilla, Surco
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Lima
Peru |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Families eligible for the trial must comply with all of the following at recruitment:
1. Have at least one child <20 months living in the home
2. Use solid fuels as main energy source for cooking/heating
3. Have access to piped water in the yard or the community where the kitchen connections can be made
4. Do not plan to move within the next 24 months
Exclusion criteria:
1. Participate in the Peruvian national programme on early child development (PNCM)
2. The child has any congenital or chronic disease
3. Refusal to participate
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diarrhoea, acute respiratory infections and early child development
Not Applicable
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Intervention(s)
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The interventions will be implemented as a randomised controlled trial with a 2x2 full factorial design. This design applies two intervention packages individually and in combination:
1. An environmental health intervention comprised of improved biomass cookstoves, kitchen sinks and hygiene education (IHIP)
2. An early child development program applied by the Peruvian state (ECD)
This design leads to four potential experimental conditions with a 1:1:1:1 allocation ratio. Communities in two poor rural provinces of the Peruvian Andes will be randomly allocated to the three intervention and one control group:
1. IHIP + ECD
2. IHIP
3. ECD
4. Control: the control group did not receive any of the interventions during the trial and follow-up period. However, participants in the control group will receive all the interventions (kitchen stove and sink) at the end of study.
The four intervention arms are assessed simultaneously during 12 months for a primary endpoint of changes in ECD and health morbidity in children under 36 months of age.
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Primary Outcome(s)
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1. Diarrhoea incidence: cases recorded weekly during 12 months of follow-up with a paper-based questionnaire using the WHO protocol/definition of diarrhoea (at least three loose stools passed within 24 hours)
2. Age standardized mean score of psychomotoric assessment: cognitive, language and motor development will be assessed twice, at baseline and end of study in children <3 years of age. The assessment will be carried out by trained local fieldworkers and trained psychologists using nationally and internationally standardised validated and comparable tools. ECD status is measured with a Peruvian validated tool (ESDI) at the baseline and end of study and with an international validate tool (Bayley Scales of Infant Development) at the end of study.
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Secondary Outcome(s)
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1. Compliance to use the interventions, recorded weekly during 12 months of follow-up
2. Acute respiratory infections incidence during 12 months of follow-up: ARI cases are recorded weekly with a paper-based questionnaire using the WHO/IMCI protocol for diagnosis. ARI will be diagnosed in children <3 years of age by trained local fieldworkers using the IMCI protocol: presence of cough and fever and observable signs: difficult breathing (>60 breaths per minute and >50 breaths per minute in children < 1 years and > 1 year respectively), chest in-drawing, stridor or other danger signs (i.e. vomiting, being lethargic)
3. Incidence of severe cases of diarrhoea such as persistent diarrhoea (lasts 14 days or longer) and bloody diarrhoea
4. Household and personal exposure to carbon monoxide (CO) and particle matter (PM2.5) during 12 months of follow-up. Household Air Pollution (HAP) assessment is conducted at various time points (4 time points) in a sub-sample of participants (N=40)
5. Microbiological contamination (E.coli) in drinking water. This analysis is carried out by a trained biologist for all study participants at the baseline and end of study, and in a sub-sample of participants (N=40) at various time points over 12 months (4 measurements). The method used for the microbiological analysis is the membrane filtration method (delAgua)
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Source(s) of Monetary Support
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UBS Optimus Foundation, Grand Challenges Canada
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Ethics review
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Status:
Approval date:
Contact:
The Cayeteno Heredia University ethics review board, 02/11/2014
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2017 |
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URL:
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