Home Fortification of Complementary Foods in Bihar India
Primary Purpose
Anemia, Malnutrition
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Home Fortification Product (HFP)
Infant and Young Child Feeding (IYCF) Practices Counseling
Sponsored by
About this trial
This is an interventional other trial for Anemia focused on measuring Vitamins, Public Health, Nutrition
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
Sites / Locations
- CARE-India
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Home Fortification and Counseling
Improved Child Feeding Practices (IYCF) Counseling
Arm Description
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.
Participants ages 6 to 18 months will receive improved young child feeding practices (IYCF) counseling from a front line worker.
Outcomes
Primary Outcome Measures
Number of home fortification sachets consumed
The number of sachets consumed versus those received by participants within seven days of distribution.
Number of home fortification sachets consumed
The number of sachets consumed versus those received by participants within thirty one days of distribution.
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.
Secondary Outcome Measures
Frequency of home visits
The number of times a front-line worker (FLW) visits one home within a twelve month period.
Frequency of home fortification sachet distribution
The number of times a front-line worker (FLW) distributes home fortification sachets within a twelve month period.
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.
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.
Complementary Feeding Rate
The percent of children initiating complementary feeding at six months.
Number of daily meals
The number of meals consumed per child in 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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02593136
Brief Title
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
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Malnutrition
Keywords
Vitamins, Public Health, Nutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11861 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home Fortification and Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Improved Child Feeding Practices (IYCF) Counseling
Arm Type
Experimental
Arm Description
Participants ages 6 to 18 months will receive improved young child feeding practices (IYCF) counseling from a front line worker.
Intervention Type
Dietary Supplement
Intervention Name(s)
Home Fortification Product (HFP)
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Infant and Young Child Feeding (IYCF) Practices Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of home fortification sachets consumed
Description
The number of sachets consumed versus those received by participants within seven days of distribution.
Time Frame
Within 7 days (Up to 7 days)
Title
Number of home fortification sachets consumed
Description
The number of sachets consumed versus those received by participants within thirty one days of distribution.
Time Frame
Within 31 days (Up to 31 days)
Title
Change in hemoglobin concentration
Description
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.
Time Frame
Baseline (month 0), Endline (month 12)
Secondary Outcome Measure Information:
Title
Frequency of home visits
Description
The number of times a front-line worker (FLW) visits one home within a twelve month period.
Time Frame
Up to 12 months
Title
Frequency of home fortification sachet distribution
Description
The number of times a front-line worker (FLW) distributes home fortification sachets within a twelve month period.
Time Frame
Up to twelve months
Title
Change in body length
Description
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.
Time Frame
Baseline (month 0), Endline (month 12)
Title
Change in body weight
Description
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.
Time Frame
Baseline (month 0), Endline (month 12)
Title
Complementary Feeding Rate
Description
The percent of children initiating complementary feeding at six months.
Time Frame
Month 6 (Up to six months)
Title
Number of daily meals
Description
The number of meals consumed per child in one day.
Time Frame
Within 24 hours (Up to one day)
Title
Quantity of food
Description
The amount of food consumed by a child per meal in the home fortification and IYCF arm versus the IYCF alone arm.
Time Frame
Within 24 hours (Up to one day)
Title
Consistency of foods
Description
The type of food textures (thick versus thin) consumed within 24 hours in the home fortification and IYCF arm versus the IYCF alone arm.
Time Frame
Within 24 hours (Up to one day)
Title
Diversity of foods
Description
The number of different food groups consumed in one day in the home fortification and IYCF arm versus the IYCF alone arm.
Time Frame
Within 24 hours (Up to one day)
Title
Front-line worker motivation
Description
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.
Time Frame
Endline (Up to 9 months)
Title
Change Developmental Milestones Checklist-II (DMC-II)
Description
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.
Time Frame
Baseline (month 0), Endline (month 12)
Title
A-not-B task performance
Description
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.
Time Frame
Endline (month 12)
Title
Elicited imitation task performance
Description
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.
Time Frame
Endline (month 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reynaldo Martorell, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CARE-India
City
Patna
State/Province
Bihar
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34302748
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.
Results Reference
derived
PubMed Identifier
28615374
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.
Results Reference
derived
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Home Fortification of Complementary Foods in Bihar India
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