NCT01679535

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

3.1 years

First QC Date

August 29, 2012

Last Update Submit

March 9, 2024

Conditions

Keywords

Infant nutrition disorderChild nutrition disordersMalnutritionProtein-energy malnutrition

Outcome Measures

Primary Outcomes (1)

  • malnutrition prevalence

    Child malnutrition rates, as measured by the prevalence of underweight, wasting, and growth stunting of the children in each group

    Measured when children are 24 months of age

Secondary Outcomes (1)

  • Child growth

    Measured when children are 24 months of age

Other Outcomes (1)

  • Prevalence of diarrhea

    Prevalence assessed when children reach 24 months of age

Study Arms (1)

Intervention

EXPERIMENTAL

nutrition and hygiene education by community health workers

Behavioral: nutrition and hygiene education

Interventions

Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers

Intervention

Eligibility Criteria

Age1 Month - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child of a mother living in the catchment area of the study who delivered during the enrollment period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Child Nutrition DisordersInfant Nutrition DisordersMalnutritionProtein-Energy Malnutrition

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesProtein DeficiencyDeficiency Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Angelo J Tomedi, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2012

First Posted

September 6, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations