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A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Nairobi
Information provided by (Responsible Party):
Angelo Tomedi, University of New Mexico
ClinicalTrials.gov Identifier:
NCT01679535
First received: August 29, 2012
Last updated: January 1, 2013
Last verified: January 2013
History of Changes
  Purpose

This study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of Kenya.


Condition Intervention
Child Nutrition Disorders
 Behavioral: nutrition and hygiene education

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • malnutrition prevalence [ Time Frame: Measured when children are 24 months of age ] [ Designated as safety issue: No ]
    Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group


Secondary Outcome Measures:
  • Child growth [ Time Frame: Measured when children are 24 months of age ] [ Designated as safety issue: No ]
    Child growth as measured by change in z score of the children in each group


Other Outcome Measures:
  • Prevalence of diarrhea [ Time Frame: Prevalence assessed when children reach 24 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 570
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
nutrition and hygiene education by community health workers
 Behavioral: nutrition and hygiene education
Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers

  Eligibility

Ages Eligible for Study:   1 Month to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Child of a mother living in the catchment area of the study who delivered during the enrollment period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679535

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
University of Nairobi
Investigators
Principal Investigator: Angelo J Tomedi, MD University of New Mexico
  More Information

Publications:

Responsible Party: Angelo Tomedi, Visiting Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01679535     History of Changes
Other Study ID Numbers: TOMEDI-12-049
Study First Received: August 29, 2012
Last Updated: January 1, 2013
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

Keywords provided by University of New Mexico:
Infant nutrition disorder
Child nutrition disorders
Malnutrition
Protein-energy malnutrition

Additional relevant MeSH terms:
Child Nutrition Disorders
Nutrition Disorders
Malnutrition

ClinicalTrials.gov processed this record on May 21, 2013