Home Fortification of Complementary Foods in Bihar India

Anemia Clinical Trial

Official title:

Assessing Feasibility and Program Effectiveness of Home Fortification of Complementary Foods in Bihar: A Cluster Randomized Community Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02593136
• Other study ID #: IRB00065311
• Status: Completed
• Phase: N/A
• First received: October 29, 2015
• Last updated: March 10, 2017
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11861
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children less than six months of age

• Children greater than eighteen months of age

Related Conditions & MeSH terms

• Anemia
• Malnutrition

Intervention

Dietary Supplement:
• 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)

Other:
• 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.

Locations

Country	Name	City	State
India	CARE-India	Patna	Bihar

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of home fortification sachets consumed	The number of sachets consumed versus those received by participants within seven days of distribution.	Within 7 days (Up to 7 days)
Primary	Number of home fortification sachets consumed	The number of sachets consumed versus those received by participants within thirty one days of distribution.	Within 31 days (Up to 31 days)
Primary	Change in hemoglobin concentration	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.	Baseline (month 0), Endline (month 12)
Secondary	Frequency of home visits	The number of times a front-line worker (FLW) visits one home within a twelve month period.	Up to 12 months
Secondary	Frequency of home fortification sachet distribution	The number of times a front-line worker (FLW) distributes home fortification sachets within a twelve month period.	Up to twelve months
Secondary	Change in body length	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.	Baseline (month 0), Endline (month 12)
Secondary	Change in body weight	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.	Baseline (month 0), Endline (month 12)
Secondary	Complementary Feeding Rate	The percent of children initiating complementary feeding at six months.	Month 6 (Up to six months)
Secondary	Number of daily meals	The number of meals consumed per child in one day.	Within 24 hours (Up to one day)
Secondary	Quantity of food	The amount of food consumed by a child per meal in the home fortification and IYCF arm versus the IYCF alone arm.	Within 24 hours (Up to one day)
Secondary	Consistency of foods	The type of food textures (thick versus thin) consumed within 24 hours in the home fortification and IYCF arm versus the IYCF alone arm.	Within 24 hours (Up to one day)
Secondary	Diversity of foods	The number of different food groups consumed in one day in the home fortification and IYCF arm versus the IYCF alone arm.	Within 24 hours (Up to one day)
Secondary	Front-line worker motivation	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.	Endline (Up to 9 months)
Secondary	Change Developmental Milestones Checklist-II (DMC-II)	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.	Baseline (month 0), Endline (month 12)
Secondary	A-not-B task performance	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.	Endline (month 12)
Secondary	Elicited imitation task performance	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.	Endline (month 12)