Dataset Information

A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings.

ABSTRACT:

Background

Exposure to unhealthy environments and inadequate child stimulation are main risk factors that affect children's health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effects. We present the design and baseline findings of a cluster-randomised controlled trial to evaluate the impact of an integrated home-environmental intervention package and an early child development programme to improve diarrhoea, acute respiratory infections and childhood developmental outcomes in children under 36?months of age living in resource-limited rural Andean Peru.

Methods

We collected baseline data on children's developmental performance, health status and demography as well as microbial contamination in drinking water. In a sub-sample of households, we measured indoor kitchen 24-h air concentration levels of carbon monoxide (CO) and fine particulate matter (PM_2.5) and CO for personal exposure.

Results

We recruited and randomised 317 children from 40 community-clusters to four study arms. At baseline, all arms had similar health and demographic characteristics, and the developmental status of children was comparable between arms. The analysis revealed that more than 25% of mothers completed primary education, a large proportion of children were stunted and diarrhoea prevalence was above 18%. Fifty-two percent of drinking water samples tested positive for thermo-tolerant coliforms and the occurrence of E.coli was evenly distributed between arms. The mean levels of kitchen PM_2.5 and CO concentrations were 213??g/m³ and 4.8?ppm, respectively.

Conclusions

The trial arms are balanced with respect to most baseline characteristics, such as household air and water pollution, and child development. These results ensure the possible estimation of the trial effectiveness. This trial will yield valuable information for assessing synergic, rational and cost-effective benefits of the combination of home-based interventions.

Trial registry

ISRCTN-26548981.

SUBMITTER: Hartinger SM

PROVIDER: S-EPMC7115072 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings.

Hartinger Stella M SM Nuño Nestor N Hattendorf Jan J Verastegui Hector H Karlen Walter W Ortiz Mariela M Mäusezahl Daniel D

BMC medical research methodology 20200402 1

<h4>Background</h4>Exposure to unhealthy environments and inadequate child stimulation are main risk factors that affect children's health and wellbeing in low- and middle-income countries. Interventions that simultaneously address several risk factors at the household level have great potential to reduce these negative effects. We present the design and baseline findings of a cluster-randomised controlled trial to evaluate the impact of an integrated home-environmental intervention package and ...[more]

PMID: 32241260

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Project description:BackgroundUnsafe drinking water, poor sanitation and hygiene, exposure to household air pollution and low cognitive and socio-emotional stimulation are risk factors affecting children in low- and middle-income countries. We implemented an integrated home-environmental intervention package (IHIP), comprising a kitchen sink, hygiene education and a certified improved biomass cookstove, and an early child development (ECD) programme to improve children´s health and developmental outcomes in the rural high-altitude Andes of Peru.MethodsWe conducted a one-year cluster-randomised controlled trial among 317 children < 36 months divided into 4 arms (IHIP + ECD, IHIP, ECD, and Control) and 40 clusters (10 clusters per arm). ECD status (socio-emotional, fine and gross motor, communication, cognitive skills, and an overall performance) measured with the Peruvian Infant Development Scale and the occurrence of self-reported child diarrhoea from caretakers were primary outcomes. Secondary outcomes included the occurrence of acute respiratory infections and the presence of thermo-tolerant faecal bacteria in drinking water. The trial was powered to compare each intervention against its control arm but it did not allow pairwise comparisons among the four arms. Primary analysis followed the intention-to-treat principle. For the statistical analysis, we employed generalised estimating equation models with robust standard errors and an independent correlation structure.ResultsWe obtained ECD information from 101 children who received the ECD intervention (individually and combined with IHIP) and 102 controls. Children who received the ECD intervention performed better in all the domains compared to controls. We found differences in the overall performance (64 vs. 39%, odd ratio (OR): 2.8; 95% confidence interval (CI): 1.6-4.9) and the cognitive domain (62 vs 46%, OR: 1.9; 95% CI: 1.1-3.5). Data analysis of child morbidity included 154 children who received the IHIP intervention (individually and combined with ECD) and 156 controls. We recorded 110,666 child-days of information on diarrhoea morbidity and observed 1.3 mean episodes per child-year in the children who received the IHIP intervention and 1.1 episodes in the controls. This corresponded to an incidence risk ratio of 1.2 (95% CI: 0.8-1.7).ConclusionsChild stimulation improved developmental status in children, but there was no health benefit associated with the home-environmental intervention. Limited year-round access to running water at home and the possible contamination of drinking water after boiling were two potential factors linked to the lack of effect of the home-environmental intervention. Potential interactions between ECD and home-environmental interventions need to be further investigated.Trial registrationISRCTN, ISRCTN-26548981. Registered 15 January 2018-Retrospectively registered, https://doi.org/10.1186/ISRCTN26548981 .

Project description:BackgroundDespite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens.Methods/designThis randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period.DiscussionWe briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements.Trial registrationhttp://www.clinicaltrials.govNCT00302718.

Dataset Information

A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings.

Background

Methods

Results

Conclusions

Trial registry

Publications

A factorial cluster-randomised controlled trial combining home-environmental and early child development interventions to improve child health and development: rationale, trial design and baseline findings.

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