Home Fortification of Complementary Foods in Bihar India

Not Applicable

Completed

• Conditions: Anemia; Malnutrition
• Interventions: Dietary Supplement: Home Fortification Product (HFP); Other: Infant and Young Child Feeding (IYCF) Practices Counseling

• Registration Number: NCT02593136
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-10
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11861

Inclusion Criteria

• Randomly selected children living within Health-Sub Centers (HSC) in West Champaran Bihar

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Exclusion Criteria

• Children less than six months of age
• Children greater than eighteen months of age

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home Fortification and Counseling	Home Fortification Product (HFP)	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.
Improved Child Feeding Practices (IYCF) Counseling	Infant and Young Child Feeding (IYCF) Practices Counseling	Participants ages 6 to 18 months will receive improved young child feeding practices (IYCF) counseling from a front line worker.
Home Fortification and Counseling	Infant and Young Child Feeding (IYCF) Practices 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.

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin concentration	Baseline (month 0), Endline (month 12)	Hemoglobin concentration will be collected by taking a small blood sample via finger or heal prick. A hemoglobin level below 7 g/dl is considered severe anemia.
Number of home fortification sachets consumed	Within 31 days (Up to 31 days)	The number of sachets consumed versus those received by participants within thirty one days of distribution.

Secondary Outcome Measures

Name	Time	Method
Quantity of food	Within 24 hours (Up to one day)	The amount of food consumed by a child per meal in the home fortification and IYCF arm versus the IYCF alone arm.
Consistency of foods	Within 24 hours (Up to one day)	The type of food textures (thick versus thin) consumed within 24 hours in the home fortification and IYCF arm versus the IYCF alone arm.
Front-line worker motivation	Endline (Up to 9 months)	Front-line worker (FLW) motivation to disseminate enhanced counseling and home fortification products will be measured at the end of study by the FLW survey. The FLW survey consists of questions regarding experience and perceived impact on work burden.
Change in body length	Baseline (month 0), Endline (month 12)	Child length will be measured using a SECA 417 length measuring board. Its measuring range is 10-100 cm with a graduation of 1 mm.
Complementary Feeding Rate	Month 6 (Up to six months)	The percent of children initiating complementary feeding at six months.
A-not-B task performance	Endline (month 12)	Child executive function will be measured by direct child assessment using the A-not-B task in children 12-18 months of age only. Whether or not the child correctly identifies the location of a hidden toy is method of assessing development in early life.
Change Developmental Milestones Checklist-II (DMC-II)	Baseline (month 0), Endline (month 12)	Child development will be measured using the Developmental Milestones Checklist-II (DMC-II). The DMC-II is a 75-item parent report questionnaire evaluating gross motor, fine motor, language, personal-social skill development in children who are 3 to 24 months in age. The DMC-II has been slightly modified for this study by adding 7 items assessing cognitive development. The exact number of items administered depends on responses to previous items and the total range of score varies. Higher scores indicate increased development.
Number of daily meals	Within 24 hours (Up to one day)	The number of meals consumed per child in one day.
Elicited imitation task performance	Endline (month 12)	Child memory will be measured by direct child assessment using the Elicited imitation tasks in children 12-18 months of age only. Elicited imitation tasks are a tool to diagnose communication deficiencies in children. This test assesses whether or not a child can imitate the order of events of a sequence modeled by the evaluator.
Frequency of home visits	Up to 12 months	The number of times a front-line worker (FLW) visits one home within a twelve month period.
Frequency of home fortification sachet distribution	Up to twelve months	The number of times a front-line worker (FLW) distributes home fortification sachets within a twelve month period.
Change in body weight	Baseline (month 0), Endline (month 12)	Child body weight will be measured using a SECA 874 mother-baby digital scale with capacity of 200 kg and graduation of 50 g \< 150 kg \> 100 g.
Diversity of foods	Within 24 hours (Up to one day)	The number of different food groups consumed in one day in the home fortification and IYCF arm versus the IYCF alone arm.

Trial Locations

Locations (1)

CARE-India; 🇮🇳 Patna, Bihar, India