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

Primary Purpose

Malnutrition, Undernutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lipid-based nutritional supplement
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

5 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All healthy children between the ages of 5-18 months old and their mothers who are residents of the municipalities of Santa Lucia, Magdalena and San Antonio who do not present any of the medical conditions listed in the exclusion criteria.
  • Mothers have understood and signed consent forms to enable their children to participate in the study. They were willing to have their child participate in one or more blood draws, bi-monthly sessions: 1) nutrition classes and food voucher and lipid-based nutritional supplement and 2) height/weight monitoring, dietary intake questionnaire, and health outcome information. As well as the additional data assessments necessary to be considered active participants in the study.

Exclusion Criteria:

  • Children with congenital anomalies, mental retardation, severe physical handicap, under-nutrition caused by medical conditions that contribute to under-nutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, chronic diseases such as tuberculosis, etc.
  • Children with a known allergy to peanuts and eggs will also be excluded from the study, 30% of children with known allergies to nuts also have an allergy to eggs.
  • Plans to move or change their place of residence outside of the study region in the next 2 months would make them ineligible.
  • Mothers who are younger than 16 years of age will be excluded from the study. Women younger than 16 might not understand the consent process and the importance of following the guidelines established in the research, therefore we chose not to include this group as "eligible" participants.
  • Children who are <= -2 standard deviations below the norm for z score for weight for age. These children are severely malnourished and need to be carefully followed under the supervision of a qualified health care provider.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Nutrition intervention

    Control

    Arm Description

    Receives a month's supply of the nutrition supplement, Plumpy'doz®, in addition to food voucher for each month. Participants were also allowed to attend monthly educational sessions.

    Receives food vouchers each month.

    Outcomes

    Primary Outcome Measures

    Change from baseline in height at 12 months
    Participating children were measured by trained staff every month during the 12 month intervention.
    Change from baseline in hemoglobin status at 12 months
    Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Change from baseline in serum transferrin status at 12 months
    Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Change from baseline in C-Reactive Protein levels at 12 months
    C-Reactive Protein was measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.
    Change from baseline in weight at 12 months
    Participating children were weighed by trained staff every month during the 12 month intervention.

    Secondary Outcome Measures

    Change from baseline in zinc levels at 12 months
    Zinc status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Change from baseline in food insecurity status at 12 months
    Assessment teams administered a scored questionnaire at baseline and month 12 of the intervention.
    Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months
    Assessment teams administered a 24-Hour Food Recall every month of the intervention.
    Change from baseline in various health outcomes at 12 months
    Assessment teams administered a scored questionnaire every month of the intervention.
    Change from baseline in acceptability of nutrition supplement at 12 months
    Assessment teams administered a scored questionnaire at baseline, month 6, and month 12 of the intervention
    Change from baseline in folate status at 12 months
    Folate status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Change from baseline in vitamin B12 status at 12 months
    Vitamin B12 was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.

    Full Information

    First Posted
    March 5, 2011
    Last Updated
    July 31, 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
    NCT01312987
    Brief Title
    Improving Nutrition and Health Outcomes in Intibuca, Honduras (MANI I)
    Acronym
    MANI I
    Official Title
    Improving Nutrition and Health Outcomes in Intibuca, Honduras
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    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 assess what impact an integrated educational and feeding intervention delivered to infants and children has on growth (weight and height), development (cognitive and gross motor), nutrition (dietary behaviors, food insecurity, and micronutrient status - folate, iron, zinc, vitamin A, vitamin D), and morbidity (respiratory and diarrheal) outcomes. A randomized community trial was used to implement a nutrition intervention program consisting of monthly education sessions, a lipid-based nutrition supplement, and food vouchers for local staples.

    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
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Nutrition intervention
    Arm Type
    Experimental
    Arm Description
    Receives a month's supply of the nutrition supplement, Plumpy'doz®, in addition to food voucher for each month. Participants were also allowed to attend monthly educational sessions.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Receives food vouchers each month.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lipid-based nutritional supplement
    Other Intervention Name(s)
    Plumpy'doz®
    Intervention Description
    After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows: 3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months
    Primary Outcome Measure Information:
    Title
    Change from baseline in height at 12 months
    Description
    Participating children were measured by trained staff every month during the 12 month intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in hemoglobin status at 12 months
    Description
    Hemoglobin status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in serum transferrin status at 12 months
    Description
    Serum transferritin was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in C-Reactive Protein levels at 12 months
    Description
    C-Reactive Protein was measured from dried blood spots collected at baseline, month 6, and month 12 of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in weight at 12 months
    Description
    Participating children were weighed by trained staff every month during the 12 month intervention.
    Time Frame
    Baseline to month 12
    Secondary Outcome Measure Information:
    Title
    Change from baseline in zinc levels at 12 months
    Description
    Zinc status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in food insecurity status at 12 months
    Description
    Assessment teams administered a scored questionnaire at baseline and month 12 of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in dietary intake based on 24-Hour Food Recall at 12 months
    Description
    Assessment teams administered a 24-Hour Food Recall every month of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in various health outcomes at 12 months
    Description
    Assessment teams administered a scored questionnaire every month of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in acceptability of nutrition supplement at 12 months
    Description
    Assessment teams administered a scored questionnaire at baseline, month 6, and month 12 of the intervention
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in folate status at 12 months
    Description
    Folate status was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Time Frame
    Baseline to month 12
    Title
    Change from baseline in vitamin B12 status at 12 months
    Description
    Vitamin B12 was measured from blood samples taken by finger pricks at baseline, month 6, and month 12 of the intervention.
    Time Frame
    Baseline to month 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Months
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All healthy children between the ages of 5-18 months old and their mothers who are residents of the municipalities of Santa Lucia, Magdalena and San Antonio who do not present any of the medical conditions listed in the exclusion criteria. Mothers have understood and signed consent forms to enable their children to participate in the study. They were willing to have their child participate in one or more blood draws, bi-monthly sessions: 1) nutrition classes and food voucher and lipid-based nutritional supplement and 2) height/weight monitoring, dietary intake questionnaire, and health outcome information. As well as the additional data assessments necessary to be considered active participants in the study. Exclusion Criteria: Children with congenital anomalies, mental retardation, severe physical handicap, under-nutrition caused by medical conditions that contribute to under-nutrition such as heart disease, kidney failure, face and throat problems that interfere with swallowing, medical problems interfering with the absorption of food, chronic diseases such as tuberculosis, etc. Children with a known allergy to peanuts and eggs will also be excluded from the study, 30% of children with known allergies to nuts also have an allergy to eggs. Plans to move or change their place of residence outside of the study region in the next 2 months would make them ineligible. Mothers who are younger than 16 years of age will be excluded from the study. Women younger than 16 might not understand the consent process and the importance of following the guidelines established in the research, therefore we chose not to include this group as "eligible" participants. Children who are <= -2 standard deviations below the norm for z score for weight for age. These children are severely malnourished and need to be carefully followed under the supervision of a qualified health care provider.
    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 (MANI I)

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