Home Fortification of Complementary Foods in Bihar India

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

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Malnutrition
• Intervention / Treatment: Dietary supplement: Home Fortification Product (HFP); Other: Infant and Young Child Feeding (IYCF) Practices Counseling

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 Type: Interventional
• Enrollment (Actual): 11861
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Bihar
    • Patna, Bihar, India
      • CARE-India

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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)
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)
Complementary Feeding Rate	The percent of children initiating complementary feeding at six months.	Month 6 (Up to six months)
Number of daily meals	The number of meals consumed per child in one day.	Within 24 hours (Up to one day)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Emory University

Publications and helpful links

General Publications

• Keats EC, Das JK, Bhutta ZA. Micronutrient powders and diarrhoea risk in infants and young children - Authors' reply. Lancet Child Adolesc Health. 2021 Aug;5(8):e29-e30. doi: 10.1016/S2352-4642(21)00164-4. No abstract available.
• Larson LM, Young MF, Ramakrishnan U, Webb Girard A, Verma P, Chaudhuri I, Srikantiah S, Martorell R. A Cross-Sectional Survey in Rural Bihar, India, Indicates That Nutritional Status, Diet, and Stimulation Are Associated with Motor and Mental Development in Young Children. J Nutr. 2017 Aug;147(8):1578-1585. doi: 10.3945/jn.117.251231. Epub 2017 Jun 14.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Nutrition; Public Health; Vitamins
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: IRB00065311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No