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

• Published in: Contemporary clinical trials 2011-11, Vol.32 (6), p.864-873
• Main Authors: Hartinger, S.M, Lanata, C.F, Hattendorf, J, Gil, A.I, Verastegui, H, Ochoa, T, Mäusezahl, D
• Format: Article
• Language: English
• Subjects: Acute lower respiratory infections; Air. Soil. Water. Waste. Feeding; Biological and medical sciences; Cardiovascular; Child; Child health; Child, Preschool; Community randomised trial; Diarrhoea; Disinfection - methods; Environment. Living conditions; Environmental Exposure - adverse effects; Environmental Illness - epidemiology; Environmental Illness - prevention & control; Epidemiology. Vaccinations; Female; Follow-Up Studies; Gastroenterology. Liver. Pancreas. Abdomen; General aspects; Hand-washing; Hematology, Oncology and Palliative Medicine; Household Articles; Humans; Hygiene; Incidence; Infant; Infectious diseases; Male; Medical sciences; Other diseases. Semiology; Peru - epidemiology; Public health. Hygiene; Public health. Hygiene-occupational medicine; Retrospective Studies; Rural Population; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Sunlight; Water Supply - standards
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2011.06.006

Abstract Introduction Pneumonia and diarrhoea are leading causes of death in children. There is a need to develop effective interventions. Objective We present the design and baseline findings of a community-randomised controlled trial in rural Peru to evaluate the health impact of an Integrated Home-based Intervention Package in children aged 6 to 35 months. Methods We randomised 51 communities. The intervention was developed through a community-participatory approach prior to the trial. They comprised the construction of improved stoves and kitchen sinks, the promotion of hand washing, and solar drinking water disinfection (SODIS). To reduce the potential impact of non-blinding bias, a psychomotor stimulation intervention was implemented in the control arm. The baseline survey included anthropometric and socio-economic characteristics. In a sub-sample we determined the level of faecal contamination of drinking water, hands and kitchen utensils and the prevalence of diarrhoegenic Escherichia coli in stool specimen. Results We enrolled 534 children. At baseline all households used open fires and 77% had access to piped water supplies. E. coli was found in drinking water in 68% and 64% of the intervention and control households. Diarrhoegenic E. coli strains were isolated from 45/139 stool samples. The proportion of stunted children was 54%. Conclusions Randomization resulted in comparable study arms. Recently, several critical reviews raised major concerns on the reliability of open health intervention trials, because of uncertain sustainability and non-blinding bias. In this regard, the presented trial featuring objective outcome measures, a simultaneous intervention in the control communities and a 12-month follow up period will provide valuable evidence.