Improving Nutrition and Health Outcomes in Intibuca, Honduras

NCT ID: NCT01303016

Last Updated: 2011-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 639 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

Malnutrition; Undernutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Nutrition supplement

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.

Group Type: EXPERIMENTAL

Chispuditos

Intervention Type: DIETARY_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.

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chispuditos

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Mathile Institute for the Advancement of Human Nutrition

OTHER

Sponsor Role: collaborator

Shoulder to Shoulder

OTHER

Sponsor Role: lead

Responsible Party

Shoulder to Shoulder

Principal Investigators

Jeff Heck, MD

Role: PRINCIPAL_INVESTIGATOR

Shoulder to Shoulder

Other Identifiers

MANI II, Shoulder to Shoulder

Identifier Type: -

Identifier Source: org_study_id