Improving Nutrition and Health Outcomes in Intibuca, Honduras

Study Overview
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Brief Summary
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The purpose of this research study is to better understand how to prevent malnutrition in children under age 5 years in Intibuca, Honduras. A randomized community trial design was used to implement a nutrition program, including a complementary nutrition supplement, educational sessions, and growth and health monitoring integrated into the basic primary care package, to participants living in communities in the intervention group. Participants living in the control group communities will receive the nutrition supplement for one year following the study.

Official Title
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Improving Nutrition and Health Outcomes in Intibuca, Honduras

Conditions
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Malnutrition, Undernutrition

Intervention / Treatment
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* Dietary Supplement: Chispuditos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between the ages of 6 months and under 5 years at the time enrollment who reside in Concepcion. Exclusion Criteria: Children with congenital anomalies, mental retardation, severe physical handicap, undernutrition caused by medical conditions that contribute to undernutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, and chronic diseases such as tuberculosis, etc. Plans to move or change place of residence outside the intervention region in the next 2 months. Children whose weight for age z score falls below - 3. Children whose weight for age z score is above 3.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutrition supplement<br>Receives a month's supply of the nutrition supplement, Chispuditos, in addition to a voucher for 1lb of powdered milk each month and a voucher for 1lb of sugar every other month. | Dietary Supplement: Chispuditos<br>* Daily dose per child is 1 heaping Tablespoon of Chispuditos (using the appropriate measuring spoon provided to each participant), 1 teaspoon of sugar if desired (using appropriate measuring spoon provided to each participant), mixed with 8 ounces of water or milk. The mixture is stirred over a heat source (fire or stove) until the mixture boils for 8 minutes.<br>|
| No Intervention: Control<br>Receives a voucher for 1lb of powdered milk each month and a voucher for 1lb of sugar every other month. Participants in the control group will receive the nutrition supplement, Chispuditos, for one year after the study is complete. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height and weight | Participating children are measured and weighed by trained staff every other month during the 12 month intervention. | Every other month for 12 months | 
| Hemoglobin | Hemoglobin values are measured using a One STAT Site M meter instrument and recorded to the nearest g/dL at baseline, month 6, and month 12 of the intervention. | Baseline, month 6, and month 12 | 
| Retinol binding protein, transferrin receptor, and C-Reactive Protein | Retinol binding protein, transferrin, and C-Reactive Protein are measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention. | Baseline, month 6, and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food insecurity | Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention. | Baseline, month 6, and month 12 | 
| Health outcomes | Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention. | Baseline, month 6, and month 12 | 
| Acceptability/Sustainability of nutrition supplement | Assessment teams administer a scored questionnaire at baseline, month 3, and month 8 of the intervention | Baseline, month 3, and month 8 |