Home Fortification of Complementary Foods in Bihar India

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11861 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-03-31

Brief Summary

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This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar. The study also seeks to assess the field level worker experience with counseling and dissemination of home fortification products.

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Detailed Description

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This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar.The key objectives of this study are to examine acceptability and utilization by target population, assess impact on infant and young child feeding (IYCF) practices, evaluate impact on child growth, evaluate impact on hemoglobin concentration, and assess front line worker experience and motivation to disseminate enhanced counseling and home fortification products.

Conditions

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Anemia Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Home Fortification and Counseling

Participants aged 6 to 18 months will receive a daily supplement of vitamins and minerals in dry powder form to be taken once daily for up to nine months or up to 240 sachets. Participant caregivers will also receive improved young child feeding practices (IYCF) counseling from a front line worker.

Group Type EXPERIMENTAL

Home Fortification Product (HFP)

Intervention Type DIETARY_SUPPLEMENT

The home fortification product (HFP) is a sachet containing multiple vitamins and nutrients as follows:

Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30 mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin (Base)

Infant and Young Child Feeding (IYCF) Practices Counseling

Intervention Type OTHER

Infant and Young Child Feeding (IYCF) Practices Counseling provides direction on breast milk and milk feeding, food variety, and frequency for caregivers of children aged 6 to 18 months. Participants will be visited at least monthly by a field line worker for IYCF counseling and educational materials distribution.

Improved Child Feeding Practices (IYCF) Counseling

Participants ages 6 to 18 months will receive improved young child feeding practices (IYCF) counseling from a front line worker.

Group Type EXPERIMENTAL

Infant and Young Child Feeding (IYCF) Practices Counseling

Intervention Type OTHER

Infant and Young Child Feeding (IYCF) Practices Counseling provides direction on breast milk and milk feeding, food variety, and frequency for caregivers of children aged 6 to 18 months. Participants will be visited at least monthly by a field line worker for IYCF counseling and educational materials distribution.

Interventions

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Home Fortification Product (HFP)

The home fortification product (HFP) is a sachet containing multiple vitamins and nutrients as follows:

Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30 mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin (Base)

Intervention Type DIETARY_SUPPLEMENT

Infant and Young Child Feeding (IYCF) Practices Counseling

Infant and Young Child Feeding (IYCF) Practices Counseling provides direction on breast milk and milk feeding, food variety, and frequency for caregivers of children aged 6 to 18 months. Participants will be visited at least monthly by a field line worker for IYCF counseling and educational materials distribution.

Intervention Type OTHER