Improving Nutrition and Health Outcomes in Intibuca, Honduras

Not Applicable

• Conditions: Malnutrition; Undernutrition
• Interventions: Dietary Supplement: Chispuditos

• Registration Number: NCT01303016
• Lead Sponsor: Shoulder to Shoulder

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-05
• Last Update Posted: 2011-03-08
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 639

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition supplement	Chispuditos	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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