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The Karnataka Anemia Project 2--design and evaluation of a community-based parental intervention to improve childhood anemia cure rates: study protocol for a cluster randomized controlled trial.

Shet AS, Zwarenstein M, Mascarenhas M, Risbud A, Atkins S, Klar N, Galanti MR - Trials (2015)

Bottom Line: Improving the hemoglobin level of preschool age children could yield substantial benefits in cognitive and psychosocial development and overall health.All outcomes will be measured 6 months after the start of the intervention.Multilevel linear and logistic regression models will be used to analyze differences between intervention and control groups in outcome variables.

View Article: PubMed Central - PubMed

Affiliation: Hematology Research Division, St. Johns Research Institute, Bangalore, India. arunshet1@gmail.com.

ABSTRACT

Background: Childhood anemia is highly prevalent worldwide. Improving the hemoglobin level of preschool age children could yield substantial benefits in cognitive and psychosocial development and overall health. While evidence-based recommendations for reducing childhood anemia in high anemia prevalence countries are available, there is no experimental evidence of community centered education and counseling programs, as a route to improved acceptance of iron supplements, demonstrating beneficial effects on anemia outcomes. We report on the evaluation protocol of a complex educational intervention led by the community lay health worker (LHW) and delivered to mothers of 12-59-month-old anemic children living in and visiting village day care centers in a large district of southern India.

Methods and design: The study is designed as a cluster randomized controlled trial. The intervention is based on the social cognitive theory and aims to promote among mothers, anemia awareness, dietary modifications to increase iron intake in the child, and recognition of the need for enhanced adherence to supplemental iron in the anemic child. From 270 eligible villages in the study area, a sample of 60 villages will be randomized to intervention [n = 30] or to treatment as usual [n = 30] of the study. LHWs in the intervention arm will be trained to administer the following intervention components to mothers of anemic children: 1] monthly distribution of Iron and folic acid (IFA) supplements to mothers of anemic children, and 2] five monthly counseling sessions of mothers of anemic children covering: a] anemia awareness education b] IFA adherence counseling and assessment, c] dietary modification to improve iron intake, and d] hygiene and sanitation. LHWs in the control arm will distribute IFA to mothers of anemic children as in the intervention arm but will not provide monthly education and counseling support. The primary outcome is the difference between the two experimental groups in anemia cure rates of children found to be anemic at baseline. Secondary outcomes, assessed as differences between all participants in both experimental groups, are: change in mothers' knowledge regarding anemia; 24 hour dietary iron intake; net improvement in individual hemoglobin values; serum ferritin; and the difference in overall cluster level childhood anemia prevalence. All outcomes will be measured 6 months after the start of the intervention. Multilevel linear and logistic regression models will be used to analyze differences between intervention and control groups in outcome variables.

Discussion: This trial is designed to evaluate the effectiveness of an intervention intended to improve anemia cure rates in anemic children living in villages of Chamarajnagar, Karnataka a large district in south India. The extensive study of secondary endpoints will be used to identify possible weak points in the compliance to intervention delivery and uptake. This evaluation is one of the few large randomized trials evaluating the impact of an education and counseling intervention to reduce childhood anemia prevalence.

Trial registration: This trial was registered with ISRCTN.com (identifier: ISRCTN68413407) on 17 September 2013.

No MeSH data available.


Related in: MedlinePlus

Study schematic of the Karnataka Anemia Project 2 study to evaluate a community-based parental intervention to improve childhood anemia cure rate
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Fig1: Study schematic of the Karnataka Anemia Project 2 study to evaluate a community-based parental intervention to improve childhood anemia cure rate

Mentions: In this trial, a cluster (randomization unit) will be defined as a village in the Chamarajnagar subprovince that is randomly allocated to one of the study arms together with the ADC or (if the village has more than one ADC) the selected ADCs belonging to that village, and the corresponding LHW in charge of the ADC. Using a computerized random number generator [39], 60 villages from a total of 270 eligible villages will be randomly selected. The villages will be stratified based on the number of <6 year-old children listed in the ADC registers as resident in each village. After stratification, the selected villages will be assigned to intervention and control arms of the trial using a 1:1 ratio, in order to ensure equal representation of both strata to both arms. The observational units consist of children aged 12–59 months registered in the randomized villages and their mothers/caregivers, eligible for the study. We plan to recruit all eligible children (Fig. 1).Fig. 1


The Karnataka Anemia Project 2--design and evaluation of a community-based parental intervention to improve childhood anemia cure rates: study protocol for a cluster randomized controlled trial.

Shet AS, Zwarenstein M, Mascarenhas M, Risbud A, Atkins S, Klar N, Galanti MR - Trials (2015)

Study schematic of the Karnataka Anemia Project 2 study to evaluate a community-based parental intervention to improve childhood anemia cure rate
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4697328&req=5

Fig1: Study schematic of the Karnataka Anemia Project 2 study to evaluate a community-based parental intervention to improve childhood anemia cure rate
Mentions: In this trial, a cluster (randomization unit) will be defined as a village in the Chamarajnagar subprovince that is randomly allocated to one of the study arms together with the ADC or (if the village has more than one ADC) the selected ADCs belonging to that village, and the corresponding LHW in charge of the ADC. Using a computerized random number generator [39], 60 villages from a total of 270 eligible villages will be randomly selected. The villages will be stratified based on the number of <6 year-old children listed in the ADC registers as resident in each village. After stratification, the selected villages will be assigned to intervention and control arms of the trial using a 1:1 ratio, in order to ensure equal representation of both strata to both arms. The observational units consist of children aged 12–59 months registered in the randomized villages and their mothers/caregivers, eligible for the study. We plan to recruit all eligible children (Fig. 1).Fig. 1

Bottom Line: Improving the hemoglobin level of preschool age children could yield substantial benefits in cognitive and psychosocial development and overall health.All outcomes will be measured 6 months after the start of the intervention.Multilevel linear and logistic regression models will be used to analyze differences between intervention and control groups in outcome variables.

View Article: PubMed Central - PubMed

Affiliation: Hematology Research Division, St. Johns Research Institute, Bangalore, India. arunshet1@gmail.com.

ABSTRACT

Background: Childhood anemia is highly prevalent worldwide. Improving the hemoglobin level of preschool age children could yield substantial benefits in cognitive and psychosocial development and overall health. While evidence-based recommendations for reducing childhood anemia in high anemia prevalence countries are available, there is no experimental evidence of community centered education and counseling programs, as a route to improved acceptance of iron supplements, demonstrating beneficial effects on anemia outcomes. We report on the evaluation protocol of a complex educational intervention led by the community lay health worker (LHW) and delivered to mothers of 12-59-month-old anemic children living in and visiting village day care centers in a large district of southern India.

Methods and design: The study is designed as a cluster randomized controlled trial. The intervention is based on the social cognitive theory and aims to promote among mothers, anemia awareness, dietary modifications to increase iron intake in the child, and recognition of the need for enhanced adherence to supplemental iron in the anemic child. From 270 eligible villages in the study area, a sample of 60 villages will be randomized to intervention [n = 30] or to treatment as usual [n = 30] of the study. LHWs in the intervention arm will be trained to administer the following intervention components to mothers of anemic children: 1] monthly distribution of Iron and folic acid (IFA) supplements to mothers of anemic children, and 2] five monthly counseling sessions of mothers of anemic children covering: a] anemia awareness education b] IFA adherence counseling and assessment, c] dietary modification to improve iron intake, and d] hygiene and sanitation. LHWs in the control arm will distribute IFA to mothers of anemic children as in the intervention arm but will not provide monthly education and counseling support. The primary outcome is the difference between the two experimental groups in anemia cure rates of children found to be anemic at baseline. Secondary outcomes, assessed as differences between all participants in both experimental groups, are: change in mothers' knowledge regarding anemia; 24 hour dietary iron intake; net improvement in individual hemoglobin values; serum ferritin; and the difference in overall cluster level childhood anemia prevalence. All outcomes will be measured 6 months after the start of the intervention. Multilevel linear and logistic regression models will be used to analyze differences between intervention and control groups in outcome variables.

Discussion: This trial is designed to evaluate the effectiveness of an intervention intended to improve anemia cure rates in anemic children living in villages of Chamarajnagar, Karnataka a large district in south India. The extensive study of secondary endpoints will be used to identify possible weak points in the compliance to intervention delivery and uptake. This evaluation is one of the few large randomized trials evaluating the impact of an education and counseling intervention to reduce childhood anemia prevalence.

Trial registration: This trial was registered with ISRCTN.com (identifier: ISRCTN68413407) on 17 September 2013.

No MeSH data available.


Related in: MedlinePlus