Malnutrition, Undernutrition
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTChispuditos
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.
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
6 Months to 5 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Height and weight | Every other month for 12 months | Participating children are measured and weighed by trained staff every other month during the 12 month intervention. |
| Hemoglobin | Baseline, month 6, and month 12 | 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. |
| Retinol binding protein, transferrin receptor, and C-Reactive Protein | Baseline, month 6, and month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food insecurity | Baseline, month 6, and month 12 | Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention. |
| Health outcomes | Baseline, month 6, and month 12 | Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention. |
| Acceptability/Sustainability of nutrition supplement | Baseline, month 3, and month 8 | Assessment teams administer a scored questionnaire at baseline, month 3, and month 8 of the intervention |
Outcome results
None listed