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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Shoulder to Shoulder.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Mathile Institute for the Advancement of Human Nutrition

Information provided by:

Shoulder to Shoulder

ClinicalTrials.gov Identifier:

NCT01303016

First received: February 23, 2011

Last updated: March 5, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2011

Last Updated Date

March 5, 2011

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Height and weight [ Time Frame: Every other month for 12 months ] [ Designated as safety issue: No ]
Participating children are measured and weighed by trained staff every other month during the 12 month intervention.
Hemoglobin [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
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.

Original Primary Outcome Measures ^ICMJE

Height and weight [ Time Frame: Every other month for 12 months ] [ Designated as safety issue: No ]
Participating children are measured and weight by trained staff every other month during the 12 month intervention.
Hemoglobin [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
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.

Change History

Complete list of historical versions of study NCT01303016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Food insecurity [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Health outcomes [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Acceptability/Sustainability of nutrition supplement [ Time Frame: Baseline, month 3, and month 8 ] [ Designated as safety issue: No ]
Assessment teams administer a scored questionnaire at baseline, month 3, and month 8 of the intervention

Original Secondary Outcome Measures ^ICMJE

Food insecurity [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Health outcomes [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Acceptability/Sustainability of nutrition supplement [ Time Frame: Baseline, month 6, and month 12 ] [ Designated as safety issue: No ]
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Improving Nutrition and Health Outcomes in Intibuca, Honduras

Official Title ^ICMJE

Improving Nutrition and Health Outcomes in Intibuca, Honduras

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Malnutrition
Undernutrition

Intervention ^ICMJE

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.

Study Arm (s)

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.

Intervention: Dietary Supplement: Chispuditos
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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

639

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

6 Months to 5 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01303016

Other Study ID Numbers ^ICMJE

MANI II, Shoulder to Shoulder

Has Data Monitoring Committee

Yes

Responsible Party

Jeff Heck, MD, Executive Director, Shoulder to Shoulder

Study Sponsor ^ICMJE

Shoulder to Shoulder

Collaborators ^ICMJE

Mathile Institute for the Advancement of Human Nutrition

Investigators ^ICMJE

Principal Investigator:

Jeff Heck, MD

Shoulder to Shoulder

Information Provided By

Shoulder to Shoulder

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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