Back to resultsA Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
Primary Purpose
Child Nutrition Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nutrition and hygiene education
Sponsored by
About this trial
This is an interventional prevention trial for Child Nutrition Disorders focused on measuring Infant nutrition disorder, Child nutrition disorders, Malnutrition, Protein-energy malnutrition
Eligibility Criteria
Inclusion Criteria:
- Child of a mother living in the catchment area of the study who delivered during the enrollment period
Sites / Locations
- University of New Mexico
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
nutrition and hygiene education by community health workers
Outcomes
Primary Outcome Measures
malnutrition prevalence
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
Child growth as measured by change in z score of the children in each group
Full Information
NCT ID
NCT01679535
First Posted
August 29, 2012
Last Updated
February 4, 2015
Sponsor
University of New Mexico
Collaborators
University of Nairobi
1. Study Identification
Unique Protocol Identification Number
NCT01679535
Brief Title
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
Official Title
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
University of Nairobi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Nutrition Disorders
Keywords
Infant nutrition disorder, Child nutrition disorders, Malnutrition, Protein-energy malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
nutrition and hygiene education by community health workers
Intervention Type
Behavioral
Intervention Name(s)
nutrition and hygiene education
Intervention Description
Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers
Primary Outcome Measure Information:
Title
malnutrition prevalence
Description
Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group
Time Frame
Measured when children are 24 months of age
Secondary Outcome Measure Information:
Title
Child growth
Description
Child growth as measured by change in z score of the children in each group
Time Frame
Measured when children are 24 months of age
Other Pre-specified Outcome Measures:
Title
Prevalence of diarrhea
Time Frame
Prevalence assessed when children reach 24 months of age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Child of a mother living in the catchment area of the study who delivered during the enrollment period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo J Tomedi, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18207566
Citation
Black RE, Allen LH, Bhutta ZA, Caulfield LE, de Onis M, Ezzati M, Mathers C, Rivera J; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: global and regional exposures and health consequences. Lancet. 2008 Jan 19;371(9608):243-60. doi: 10.1016/S0140-6736(07)61690-0. No abstract available.
Results Reference
result
PubMed Identifier
18206226
Citation
Bhutta ZA, Ahmed T, Black RE, Cousens S, Dewey K, Giugliani E, Haider BA, Kirkwood B, Morris SS, Sachdev HP, Shekar M; Maternal and Child Undernutrition Study Group. What works? Interventions for maternal and child undernutrition and survival. Lancet. 2008 Feb 2;371(9610):417-40. doi: 10.1016/S0140-6736(07)61693-6.
Results Reference
result
PubMed Identifier
18289157
Citation
Dewey KG, Adu-Afarwuah S. Systematic review of the efficacy and effectiveness of complementary feeding interventions in developing countries. Matern Child Nutr. 2008 Apr;4 Suppl 1(Suppl 1):24-85. doi: 10.1111/j.1740-8709.2007.00124.x.
Results Reference
result
Learn more about this trial
A Nutrition/Hygiene Education Program for the Prevention of Child Malnutrition in Rural Kenya
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