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Completed

NCT Number: NCT02593136

Home Fortification of Complementary Foods in Bihar India

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CARE-India

Patna, Bihar, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home Fortification Product (HFP)

Dietary Supplement

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

Other

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 outcomes

  1. Number of home fortification sachets consumed

    Time frame: Within 7 days (Up to 7 days)

    The number of sachets consumed versus those received by participants within seven days of distribution.

  2. Number of home fortification sachets consumed

    Time frame: Within 31 days (Up to 31 days)

    The number of sachets consumed versus those received by participants within thirty one days of distribution.

  3. Change in hemoglobin concentration

    Time frame: Baseline (month 0), Endline (month 12)

    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 outcomes

  1. Frequency of home visits

    Time frame: Up to 12 months

    The number of times a front-line worker (FLW) visits one home within a twelve month period.

  2. Frequency of home fortification sachet distribution

    Time frame: Up to twelve months

    The number of times a front-line worker (FLW) distributes home fortification sachets within a twelve month period.

  3. Change in body length

    Time frame: Baseline (month 0), Endline (month 12)

    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.

  4. Change in body weight

    Time frame: Baseline (month 0), Endline (month 12)

    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.

  5. Complementary Feeding Rate

    Time frame: Month 6 (Up to six months)

    The percent of children initiating complementary feeding at six months.

  6. Number of daily meals

    Time frame: Within 24 hours (Up to one day)

    The number of meals consumed per child in one day.

  7. Quantity of food

    Time frame: Within 24 hours (Up to one day)

    The amount of food consumed by a child per meal in the home fortification and IYCF arm versus the IYCF alone arm.

  8. Consistency of foods

    Time frame: Within 24 hours (Up to one day)

    The type of food textures (thick versus thin) consumed within 24 hours in the home fortification and IYCF arm versus the IYCF alone arm.

  9. Diversity of foods

    Time frame: Within 24 hours (Up to one day)

    The number of different food groups consumed in one day in the home fortification and IYCF arm versus the IYCF alone arm.

  10. Front-line worker motivation

    Time frame: Endline (Up to 9 months)

    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.

  11. Change Developmental Milestones Checklist-II (DMC-II)

    Time frame: Baseline (month 0), Endline (month 12)

    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.

  12. A-not-B task performance

    Time frame: Endline (month 12)

    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.

  13. Elicited imitation task performance

    Time frame: Endline (month 12)

    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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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