Health and development effectiveness of integrated home-based interventions in rural Andean communities: a randomised trial

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26548981

Enrollment

320

Registered

2018-01-15

Start date

2015-07-02

Completion date

Unknown

Last updated

2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhoea, acute respiratory infections and early child development Not Applicable

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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 60 breaths per minute and >50 breaths per minute in children 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)	—

Measure

Time frame

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 60 breaths per minute and >50 breaths per minute in children 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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Countries

Peru

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026