Clinical trial NCT02593136: Home Fortification of Complementary Foods in Bihar India
Official title: Assessing Feasibility and Program Effectiveness of Home Fortification of Complementary Foods in Bihar: A Cluster Randomized Community Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Malnutrition
Keywords: Vitamins
Public Health
Nutrition
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 11861
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of home fortification sachets consumed
timeFrame: Within 7 days (Up to 7 days)
measure: Number of home fortification sachets consumed
timeFrame: Within 31 days (Up to 31 days)
measure: Change in hemoglobin concentration
timeFrame: Baseline (month 0), Endline (month 12)
Secondary outcomes:
measure: Frequency of home visits
timeFrame: Up to 12 months
measure: Frequency of home fortification sachet distribution
timeFrame: Up to twelve months
measure: Change in body length
timeFrame: Baseline (month 0), Endline (month 12)
measure: Change in body weight
timeFrame: Baseline (month 0), Endline (month 12)
measure: Complementary Feeding Rate
timeFrame: Month 6 (Up to six months)
measure: Number of daily meals
timeFrame: Within 24 hours (Up to one day)
measure: Quantity of food
timeFrame: Within 24 hours (Up to one day)
measure: Consistency of foods
timeFrame: Within 24 hours (Up to one day)
measure: Diversity of foods
timeFrame: Within 24 hours (Up to one day)
measure: Front-line worker motivation
timeFrame: Endline (Up to 9 months)
measure: Change Developmental Milestones Checklist-II (DMC-II)
timeFrame: Baseline (month 0), Endline (month 12)
measure: A-not-B task performance
timeFrame: Endline (month 12)
measure: Elicited imitation task performance
timeFrame: Endline (month 12)
Other outcomes:
Locations:
city: Patna
country: India
facility: CARE-India
state: Bihar
Study officials:
affiliation: Emory University
name: Reynaldo Martorell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.