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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
Shoulder to Shoulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition

Eligibility Criteria

6 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 23, 2011
    Last Updated
    March 5, 2011
    Sponsor
    Shoulder to Shoulder
    Collaborators
    The Mathile Institute for the Advancement of Human Nutrition
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    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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