Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI II)

Shoulder to Shoulder

Status: Unknown

Conditions: Malnutrition; Undernutrition

Treatments: Dietary Supplement: Chispuditos

Study type: Interventional

Funder types: Other

Identifiers

NCT01303016

MANI II, Shoulder to Shoulder

Details and patient eligibility

About

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.

Enrollment: 639 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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639 participants in 2 patient groups

Nutrition supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Chispuditos

Control

No Intervention group

Description:

Receives a voucher for 1lb of powdered milk each month and a voucher for 1lb of sugar every other month. Participants in the control group will receive the nutrition supplement, Chispuditos, for one year after the study is complete.