Condition category
Respiratory
Date applied
04/02/2010
Date assigned
14/04/2010
Last edited
08/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claudio Lanata

ORCID ID

Contact details

Instituto de Investigación Nutricional
Av. La Molina 1885
La Molina
Lima
Lima-12
Peru

Type

Scientific

Additional contact

Dr Daniel Mäusezahl

ORCID ID

Contact details

Swiss Tropical & Public Health Institute (Swiss TPH)
Socinstrasse 57
Basel
CH-4002
Switzerland
-
daniel.maeusezahl@unibas.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Integrated environmental home-based intervention package for child survival: a community randomised trial

Acronym

Peru-IHIP

Study hypothesis

An immediate and massive reduction of household burden of disease in childhood (acute respiratory infection [ARI], diarrhoea, nutrition-related illness/factors) will have a measurable impact on rural livelihoods and home economies.

Ethics approval

1. Institutio Nacional de Salud (Peruvian Ministry of Health), 12/03/2008
2. Comite Etica Investigation of the Instituto de Investigation Nutritional (IIN), 20/08/2008
3. Ethics Committee of Basel, Switzerland (EKBB), 15/09/2008

Study design

Community randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Diarrhoea, acute lower respiratory infection (ALRI), pneumonia

Intervention

Intervention arm: improved stoves, kitchen sink and hygiene, solar drinking water disinfection
Control arm: early childhood psychomotoric stimulation

The improved stoves and kitchen sink and water treatment hardware was built and introduced in the households of the intervention arm together with the hygiene component from October 2008 to January 2009. Solar water disinfection treatment was introduced January 2009. Reinforcement of the intervention messages was continuously every 2 - 3 weeks during the follow up period. Anthropometric measurements were taken monthly.

In the control arm, the psychomotoric stimulation package was explained and first delivery of the early stimulation toys was provided according to the child's age in December 2008 - January 2009. Subsequent deliveries of the psychomotoric stimulation tools and toys were according to the development level of the individual child (assessed two-monthly) during follow up.

The follow up period for data collection and monitoring lasted over 12 months from February 2009 to January 2010.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Diarrhoea incidence, longitudinal prevalence from daily diarrhoeal illness assessments, recorded by field investigators during weekly home visit for the entire 12 months follow-up period
2. Child growth parameters, taken monthly during the follow up

Secondary outcome measures

1. Compliance to use interventions, recorded by field investigators during weekly home visit for the entire 12 months follow-up period
2. Bacterial load reduction in drinking water and kitchen cloths exposed to sunlight, recorded by field investigators during weekly home visit for the entire 12 months follow-up period
3. Acceptability of the intervention and uptake in the control group after study end
Individual psychomotoric child development indicators are assessed every two months during home visit for the entire 12 months follow-up period.

Overall trial start date

01/06/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Youngest child of household between 6 - 36 months of age, either sex
2. Living permanently in each of the 653 households in 54 communities of the study area identified during a population census
3. The child has no chronic disease or congenital malformation

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

650 households and about 2000 families

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/06/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Peru

Trial participating centre

Instituto de Investigación Nutricional
Lima
Lima-12
Peru

Sponsor information

Organisation

Instituto de Investigación Nutricional (IIN) (Peru)

Sponsor details

Av. La Molina 1885
La Molina
Lima
Lima-12
Peru

Sponsor type

Research organisation

Website

http://www.iin.sld.pe/

Organisation

Swiss Tropical & Public Health Institute (Swiss TPH) (Switzerland)

Sponsor details

Socinstrasse 57
Basel
CH-4002
Switzerland
-
daniel.maeusezahl@unibas.ch

Sponsor type

Research organisation

Website

Funders

Funder type

Industry

Funder name

Private Swiss Foundation (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 rationale, trial design and baseline findings in: http://www.ncbi.nlm.nih.gov/pubmed/21762789
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27612978
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27818376

Publication citations

  1. Trial design

    Hartinger SM, Lanata CF, Hattendorf J, Gil AI, Verastegui H, Ochoa T, Mäusezahl D, A community randomised controlled trial evaluating a home-based environmental intervention package of improved stoves, solar water disinfection and kitchen sinks in rural Peru: rationale, trial design and baseline findings., Contemp Clin Trials, 2011, 32, 6, 864-873, doi: 10.1016/j.cct.2011.06.006.

Additional files

Editorial Notes

08/11/2016: Publication reference added. 12/09/2016: Publication reference added.