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AnemiaNCT02593136

Home Fortification of Complementary Foods in Bihar India

A study testing Home Fortification Product (HFP) and Infant and Young Child Feeding (IYCF) Practices Counseling in people with Anemia and Malnutrition, run by Emory University at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 18 months
Conditions the study is for
Anemia, Malnutrition
What is being tested?
Home Fortification Product (HFP) and Infant and Young Child Feeding (IYCF) Practices Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11,861 participants
Where
1 siteIndia
Study dates
Jun 2014to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Randomly selected children living within Health-Sub Centers (HSC) in West Champaran Bihar

Who cannot join

  • Children less than six months of age
  • Children greater than eighteen months of age

Trial locations and contacts

1 site in 1 country.

India1 site

  • CARE-India

    Patna, Bihar

Other trials in India

About this study

Official title: 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.

Read the 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.

Conditions
Anemia, Malnutrition
Being tested
Home Fortification Product (HFP), Infant and Young Child Feeding (IYCF) Practices Counseling
Keywords
Vitamins, Public Health, Nutrition
Medical subject headings
Anemia, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 CounselingOther

    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.

Study groups in NCT02593136
Study groupRoleWhat they receive
Home Fortification and CounselingExperimentalParticipants 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.
Receives: Dietary Supplement: Home Fortification Product (HFP); Other: Infant and Young Child Feeding (IYCF) Practices Counseling
Improved Child Feeding Practices (IYCF) CounselingExperimentalParticipants ages 6 to 18 months will receive improved young child feeding practices (IYCF) counseling from a front line worker.
Receives: Other: Infant and Young Child Feeding (IYCF) Practices Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of home fortification sachets consumed

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

    Measured: Within 7 days (Up to 7 days)

  2. Number of home fortification sachets consumed

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

    Measured: Within 31 days (Up to 31 days)

  3. 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.

    Measured: Baseline (month 0), Endline (month 12)

Secondary outcomes (13)

  1. Frequency of home visits

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

    Measured: Up to 12 months

  2. Frequency of home fortification sachet distribution

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

    Measured: Up to twelve months

  3. 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.

    Measured: Baseline (month 0), Endline (month 12)

  4. 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.

    Measured: Baseline (month 0), Endline (month 12)

  5. Complementary Feeding Rate

    The percent of children initiating complementary feeding at six months.

    Measured: Month 6 (Up to six months)

  6. Number of daily meals

    The number of meals consumed per child in one day.

    Measured: Within 24 hours (Up to one day)

  7. 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.

    Measured: Within 24 hours (Up to one day)

  8. 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.

    Measured: Within 24 hours (Up to one day)

  9. 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.

    Measured: Within 24 hours (Up to one day)

  10. 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.

    Measured: Endline (Up to 9 months)

  11. 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.

    Measured: Baseline (month 0), Endline (month 12)

  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.

    Measured: Endline (month 12)

  13. 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.

    Measured: Endline (month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2015 (estimated)
  2. Study startJun 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11,861 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02593136
Sponsor's protocol ID
IRB00065311
Status last verified
Mar 2017
First submitted
29 Oct 2015
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34302748

  • 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.

    PubMed 28615374

Questions about this trial

What is this clinical trial studying?

A study testing Home Fortification Product (HFP) and Infant and Young Child Feeding (IYCF) Practices Counseling in people with Anemia and Malnutrition, run by Emory University at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of home fortification sachets consumed (time frame: Within 7 days (Up to 7 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02593136, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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