Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI II)
Primary Purpose
Malnutrition, Undernutrition
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chispuditos
Sponsored by
About this trial
This is an interventional prevention trial for Malnutrition
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nutrition supplement
Control
Arm 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.
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.
Outcomes
Primary Outcome Measures
Height and weight
Participating children are measured and weighed by trained staff every other month during the 12 month intervention.
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.
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.
Secondary Outcome Measures
Food insecurity
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Health outcomes
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Acceptability/Sustainability of nutrition supplement
Assessment teams administer a scored questionnaire at baseline, month 3, and month 8 of the intervention
Full Information
NCT ID
NCT01303016
First Posted
February 23, 2011
Last Updated
March 5, 2011
Sponsor
Shoulder to Shoulder
Collaborators
The Mathile Institute for the Advancement of Human Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT01303016
Brief Title
Improving Nutrition and Health Outcomes in Intibuca, Honduras
Acronym
MANI II
Official Title
Improving Nutrition and Health Outcomes in Intibuca, Honduras
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shoulder to Shoulder
Collaborators
The Mathile Institute for the Advancement of Human Nutrition
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Undernutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
639 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition supplement
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Chispuditos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Height and weight
Description
Participating children are measured and weighed by trained staff every other month during the 12 month intervention.
Time Frame
Every other month for 12 months
Title
Hemoglobin
Description
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.
Time Frame
Baseline, month 6, and month 12
Title
Retinol binding protein, transferrin receptor, and C-Reactive Protein
Description
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.
Time Frame
Baseline, month 6, and month 12
Secondary Outcome Measure Information:
Title
Food insecurity
Description
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Time Frame
Baseline, month 6, and month 12
Title
Health outcomes
Description
Assessment teams administer a scored questionnaire at baseline, month 6, and month 12 of the intervention.
Time Frame
Baseline, month 6, and month 12
Title
Acceptability/Sustainability of nutrition supplement
Description
Assessment teams administer a scored questionnaire at baseline, month 3, and month 8 of the intervention
Time Frame
Baseline, month 3, and month 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Heck, MD
Organizational Affiliation
Shoulder to Shoulder
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Improving Nutrition and Health Outcomes in Intibuca, Honduras
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