Improving Nutrition and Health Outcomes in Intibuca, Honduras

Shoulder to Shoulder639 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

639

Conditions

Malnutrition Undernutrition

Interventions

ChispuditosDIETARY_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.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Height and weight

Participating children are measured and weighed by trained staff every other month during the 12 month intervention.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, month 6, and month 12

Secondary Outcomes

Food insecurity

Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.

Time frame: Baseline, month 6, and month 12

Health outcomes

Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.

Time frame: 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

Time frame: Baseline, month 3, and month 8

Data from ClinicalTrials.gov

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