Appropriate Complmentary Feeding Strategies in Infants

Study Overview
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Brief Summary
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The purpose of this study has been to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods. In this community based randomized clinical trial, the nutrition education package implemented aimed to improve hematological parameters including the micronutrient status and to see effect on growth indicators.

Detailed Description
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Transition from exclusive breast feeding to complementary feeding poses many challenges as the demand for nutrients necessary for optimum growth and development increases steadily. Malnutrition and micronutrient malnutrition can be inter-generational and affect pregnant mothers and consequently the baby may be born with deficient micronutrient stores, especially those of iron. This deficiency can be further exacerbated by sub-optimal practices of breast feeding. Globally, iron deficiency is the most common cause of anemia estimated to affect nearly 2 billion people especially preschool children. In Pakistan, 56 % of children under the age of five years are estimated to have iron deficiency anemia and 13 % are also severely malnourished. These deficiencies affect not only physical growth but also mental development with significant impact on immunity and increased burden of infections. It is uncertain what the most appropriate intervention strategy is and a wide range of options are mentioned including dietary diversification through nutrition education, provision of fortified foods, iron supplementation and home-based fortification of complementary foods with micronutrient powders such as Sprinkles. In an effort to understand the prevalence of under nutrition and develop effective interventions for improving growth and micronutrient status of infants receiving complementary foods, I undertook a prospective community-based randomized controlled efficacy trial in a representative urban population of Karachi. Infants and mothers were identified after birth and enrolled in the study to receive one of the interventions through community health workers at the age of six months. The enrolled infants were placed in three groups - defined as Nutr Education (Nutr Edu), Oral iron supplementation (OIS) and Multiple micronutrient fortification (MMF). Nutrition education component was common to all the groups. Through nutritional education sessions held in the community, dietary diversification along with continuation of breast feeding was stressed to enhance the intake of diet, rich in iron, and other micronutrients. A cohort of 451 infants (177 in group Nutr Edu, 141 in group OIS and 133 in MMF) were followed for three months (till the end of treatments) for growth, micronutrient status, and morbidity rate and thereafter followed for another three months to evaluate anthropometric parameters.

Official Title
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Appropriate Complementary Feeding Strategies in Infants: An Evaluation of Various Strategies to Assess the Growth and Health of the Infants.

Conditions
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Anemia

Intervention / Treatment
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* Behavioral: Nutritionl Education
* Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion
* Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All children between the age of 6 months to 8 months. Exclusion Criteria: Children who are sick to an extent that cannot take anythign oral were excluded from this study.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 8 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrition Education plus Multiple Micronutrient Fortification<br>In this group along with the nutritional education, multiple micronutrient fortification was given in the form of Sprinkles | Dietary Supplement: Multiple micronutrient fortification plus Nutrition Education<br> <br> |
| Active Comparator: OIS plus Nutritional Eductaion<br>In this group, along with the nutritional education, Oral Iron Supplementation was given. | Dietary Supplement: Oral Iron Supplementation along with Nturition Eductaion<br> <br> |
| Active Comparator: Nutrition Education Group<br>This is group was followed for the growth of the child and was given Nutritional Education to children's mothers. | Behavioral: Nutritionl Education<br>* to assess the change in behaviour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia | To assess the impact of supplementation and multiple micronutrient fortification in comparison to nutritional education strategy to assess the biochecmical and growth indicators | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance to intake of study medicines | Compliance was checked to ensure that subjects are taking study medicines properly. | 12 months | 
| Morbidity Assessment | Subjects were assessed on fortnighty basis to see any change in the morbidity. | 12 months | 
| Developmental Assessment | Subjects were assessed on monthly developmental milestones among the three groups. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Growth, Infants, Focus of the study is to assess the level of anemia and growth indicators among the infants