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| Name | Class |
|---|---|
| The Mathile Institute for the Advancement of Human Nutrition | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition supplement | Experimental | 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. |
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| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chispuditos | Dietary Supplement | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Heck, MD | Shoulder to Shoulder | Principal Investigator |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |