Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679535
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : February 6, 2015
Sponsor:
Collaborator:
University of Nairobi
Information provided by (Responsible Party):
Angelo Tomedi, University of New Mexico

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Child Nutrition Disorders Behavioral: nutrition and hygiene education Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
Study Start Date : November 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. malnutrition prevalence [ Time Frame: Measured when children are 24 months of age ]
    Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group


Secondary Outcome Measures :
  1. Child growth [ Time Frame: Measured when children are 24 months of age ]
    Child growth as measured by change in z score of the children in each group


Other Outcome Measures:
  1. Prevalence of diarrhea [ Time Frame: Prevalence assessed when children reach 24 months of age ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679535


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Angelo J Tomedi, MD University of New Mexico
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Layout table for additonal information
Responsible Party: Angelo Tomedi, Visiting Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT01679535    
Other Study ID Numbers: TOMEDI-12-049
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015
Keywords provided by Angelo Tomedi, University of New Mexico:
Infant nutrition disorder
Child nutrition disorders
Malnutrition
Protein-energy malnutrition
Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Nutrition Disorders
Child Nutrition Disorders