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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
  Purpose

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.


Condition Intervention
Malnutrition
Undernutrition
 Dietary Supplement: Chispuditos

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improving Nutrition and Health Outcomes in Intibuca, Honduras

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shoulder to Shoulder:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 639
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303016

Sponsors and Collaborators
Shoulder to Shoulder
Mathile Institute for the Advancement of Human Nutrition
Investigators
Principal Investigator: Jeff Heck, MD Shoulder to Shoulder
  More Information

No publications provided

Responsible Party: Jeff Heck, MD, Executive Director, Shoulder to Shoulder
ClinicalTrials.gov Identifier: NCT01303016     History of Changes
Other Study ID Numbers: MANI II, Shoulder to Shoulder
Study First Received: February 23, 2011
Last Updated: March 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013