Malnutrition, Undernutrition
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLipid-based nutritional 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
Sponsors
The Mathile Institute for the Advancement of Human Nutrition
Shoulder to Shoulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Months to 18 Months
Healthy volunteers
Yes
Inclusion criteria
* All healthy children between the ages of 5-18 months old and their mothers who are residents of the municipalities of Santa Lucia, Magdalena and San Antonio who do not present any of the medical conditions listed in the
Exclusion criteria
. * Mothers have understood and signed consent forms to enable their children to participate in the study. They were willing to have their child participate in one or more blood draws, bi-monthly sessions: 1) nutrition classes and food voucher and lipid-based nutritional supplement and 2) height/weight monitoring, dietary intake questionnaire, and health outcome information. As well as the additional data assessments necessary to be considered active participants in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in height at 12 months | Baseline to month 12 | Participating children were measured by trained staff every month during the 12 month intervention. |
| Change from baseline in hemoglobin status at 12 months | Baseline to month 12 | Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. |
| Change from baseline in serum transferrin status at 12 months | Baseline to month 12 | Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. |
| Change from baseline in C-Reactive Protein levels at 12 months | Baseline to month 12 | C-Reactive Protein was measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention. |
| Change from baseline in weight at 12 months | Baseline to month 12 | Participating children were weighed by trained staff every month during the 12 month intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in folate status at 12 months | Baseline to month 12 | Folate status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. |
| Change from baseline in zinc levels at 12 months | Baseline to month 12 | Zinc status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. |
| Change from baseline in vitamin B12 status at 12 months | Baseline to month 12 | Vitamin B12 was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention. |
| Change from baseline in food insecurity status at 12 months | Baseline to month 12 | Assessment teams administered a scored questionnaire at baseline and month 12 of the intervention. |
| Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months | Baseline to month 12 | Assessment teams administered a 24-Hour Food Recall every month of the intervention. |
| Change from baseline in various health outcomes at 12 months | Baseline to month 12 | Assessment teams administered a scored questionnaire every month of the intervention. |
| Change from baseline in acceptability of nutrition supplement at 12 months | Baseline to month 12 | Assessment teams administered a scored questionnaire at baseline, month 6, and month 12 of the intervention |
Outcome results
None listed