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
1 other identifier
interventional
11,861
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 14, 2017
March 1, 2017
1.8 years
October 29, 2015
March 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (13)
Frequency of home visits
Up to 12 months
Frequency of home fortification sachet distribution
Up to twelve months
Change in body length
Baseline (month 0), Endline (month 12)
Change in body weight
Baseline (month 0), Endline (month 12)
Complementary Feeding Rate
Month 6 (Up to six months)
- +8 more secondary outcomes
Study Arms (2)
Home Fortification and Counseling
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants ages 6 to 18 months will receive improved young child feeding practices (IYCF) counseling from a front line worker.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Randomly selected children living within Health-Sub Centers (HSC) in West Champaran Bihar
You may not qualify if:
- Children less than six months of age
- Children greater than eighteen months of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
CARE-India
Patna, Bihar, India
Related Publications (2)
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.
PMID: 34302748DERIVEDLarson 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.
PMID: 28615374DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reynaldo Martorell, PhD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 29, 2015
First Posted
October 30, 2015
Study Start
June 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 14, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share