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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 assess what impact an integrated educational and feeding intervention delivered to infants and children has on growth (weight and height), development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory and diarrheal) outcomes. A randomized community trial was used to implement a nutrition intervention program consisting of monthly education sessions, a lipid-based nutrition supplement, and food vouchers for local staples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutrition intervention | Experimental | Receives a month's supply of the nutrition supplement, Plumpy'dozĀ®, in addition to food voucher for each month. Participants were also allowed to attend monthly educational sessions. |
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| Control | No Intervention | Receives food vouchers each month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lipid-based nutritional supplement | Dietary Supplement | After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows: 3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in height at 12 months | Participating children were measured by trained staff every month during the 12 month intervention. | Baseline to month 12 |
| Change from baseline in hemoglobin status at 12 months | Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. | Baseline to month 12 |
| Change from baseline in serum transferrin status at 12 months | Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. | Baseline to month 12 |
| Change from baseline in C-Reactive Protein levels at 12 months | C-Reactive Protein was measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention. | Baseline to month 12 |
| Change from baseline in weight at 12 months | Participating children were weighed by trained staff every month during the 12 month intervention. | Baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in zinc levels at 12 months | Zinc status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. | Baseline to month 12 |
| Change from baseline in food insecurity status at 12 months |
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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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Assessment teams administered a scored questionnaire at baseline and month 12 of the intervention. |
| Baseline to month 12 |
| Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months | Assessment teams administered a 24-Hour Food Recall every month of the intervention. | Baseline to month 12 |
| Change from baseline in various health outcomes at 12 months | Assessment teams administered a scored questionnaire every month of the intervention. | Baseline to month 12 |
| Change from baseline in acceptability of nutrition supplement at 12 months | Assessment teams administered a scored questionnaire at baseline, month 6, and month 12 of the intervention | Baseline to month 12 |
| Change from baseline in folate status at 12 months | Folate status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. | Baseline to month 12 |
| Change from baseline in vitamin B12 status at 12 months | Vitamin B12 was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. | Baseline to month 12 |