Promoting Physical Growth and Positive Development in Severely Stunted Guatemalan Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-10-31

Brief Summary

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This study seeks to evaluate the impact of an intensive home-based education intervention targeting severely stunted Guatemalan children for catch up growth and improved development. Half of the children in the study will receive standard of care, which includes micronutrient supplementation and a food ration. The other half of children in the study will receive, in addition to the above, home-based dietary assessment and individualized parental nutrition education.

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Detailed Description

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Conditions

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Malnutrition Developmental Disabilities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of Care Arm

In this arm enrolled children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement.

Group Type ACTIVE_COMPARATOR

Standard-of-care nutrition support

Intervention Type DIETARY_SUPPLEMENT

Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)

Home-based Education

In the intervention arm, children will receive the national standard of care for growth support, which includes growth monitoring, a food ration, and a multiple micronutrient powder supplement. In addition, they will receive monthly home visits from a community health promoter who will provide detailed dietary assessments and individualized dietary coaching and education to parents.

Group Type EXPERIMENTAL

Home-based nutrition education

Intervention Type BEHAVIORAL

Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.

Standard-of-care nutrition support

Intervention Type DIETARY_SUPPLEMENT

Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)

Interventions

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Home-based nutrition education

Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.

Intervention Type BEHAVIORAL

Standard-of-care nutrition support

Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Child aged 6-24 months at time of enrollment
* Height/length for age Z score of less than -2.5
* Child lives with parent/legal guardian

Exclusion Criteria

* Presence of acute malnutrition (weight for length/height Z score of less than -2)
* Presence of other severe medical illness (e.g. congenital heart disease, genetic abnormality)

Minimum Eligible Age

6 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No