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

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 Overview

• Status: Unknown
• Conditions: Malnutrition; Undernutrition
• Intervention / Treatment: Dietary supplement: Chispuditos

• Study Type: Interventional
• Enrollment (Actual): 639
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height and weight	Participating children are measured and weighed by trained staff every other month during the 12 month intervention.	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.	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.	Baseline, month 6, and month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food insecurity	Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.	Baseline, month 6, and month 12
Health outcomes	Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.	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	Baseline, month 3, and month 8

Collaborators and Investigators

• Sponsor: Shoulder to Shoulder
• Collaborators: The Mathile Institute for the Advancement of Human Nutrition

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: February 23, 2011
• First Submitted That Met QC Criteria: February 23, 2011
• First Posted (Estimate): February 24, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2011
• Last Update Submitted That Met QC Criteria: March 5, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: MANI II, Shoulder to Shoulder