Improving Nutrition and Health Outcomes in Intibuca, Honduras

NCT01303016 | Unknown DMC

• 1 other identifier: MANI II, Shoulder to Shoulder
• Study Type: interventional
• Target: 639
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Food insecurity

  Baseline, month 6, and month 12

• Health outcomes

  Baseline, month 6, and month 12

• Acceptability/Sustainability of nutrition supplement

  Baseline, month 3, and month 8

Study Arms (2)

Nutrition supplement

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Chispuditos 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.

Nutrition supplement

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 6 months and under 5 years at the time enrollment who reside in Concepcion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shoulder to Shoulder: lead
• The Mathile Institute for the Advancement of Human Nutrition: collaborator

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jeff Heck, MD

  Shoulder to Shoulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: February 24, 2011
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 8, 2011

Record last verified: 2011-03