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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

Hypothesized causal pathway of the effect of the intervention and its outcome measures
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Fig2: Hypothesized causal pathway of the effect of the intervention and its outcome measures

Mentions: In the planning stage of the intervention, theoretical frameworks were developed according to Fraser et al [41]. In the Problem Theory, the mother’s knowledge, attitude, beliefs, care and control, role model, willingness to change, and parental self-efficacy were identified as malleable factors in order to influence the hygiene, dietary habits, and adherence to IFA supplements in their children. The design of the intervention is guided by the Social Cognitive Theory (SCT) [42], based on evidence in the published literature [23, 29, 31, 33, 34, 43, 44], and modulated based on discussions with stakeholders and policymakers in the Karnataka. According to the SCT, at least two principal sources of self-efficacy: verbal persuasion and performance accomplishment, are intended to mediate the effect of this intervention. The education of mothers about anemia, nutrition, IFA supplementation, and hygiene could foster the perception that their actions can control anemia in their children. This would lead to positive expectations about their children’s health outcomes, which, along with LHW facilitation of learning and positive reinforcement, could improve IFA adherence (Fig. 2).Fig. 2


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)

Hypothesized causal pathway of the effect of the intervention and its outcome measures
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig2: Hypothesized causal pathway of the effect of the intervention and its outcome measures
Mentions: In the planning stage of the intervention, theoretical frameworks were developed according to Fraser et al [41]. In the Problem Theory, the mother’s knowledge, attitude, beliefs, care and control, role model, willingness to change, and parental self-efficacy were identified as malleable factors in order to influence the hygiene, dietary habits, and adherence to IFA supplements in their children. The design of the intervention is guided by the Social Cognitive Theory (SCT) [42], based on evidence in the published literature [23, 29, 31, 33, 34, 43, 44], and modulated based on discussions with stakeholders and policymakers in the Karnataka. According to the SCT, at least two principal sources of self-efficacy: verbal persuasion and performance accomplishment, are intended to mediate the effect of this intervention. The education of mothers about anemia, nutrition, IFA supplementation, and hygiene could foster the perception that their actions can control anemia in their children. This would lead to positive expectations about their children’s health outcomes, which, along with LHW facilitation of learning and positive reinforcement, could improve IFA adherence (Fig. 2).Fig. 2

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