Supplementary Food on Prevention of Moderate Malnutrition in Children
The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico
1 other identifier
interventional
1,048
1 country
1
Brief Summary
The study will evaluate the impact of a supplementary food (cookies) in preventing the risk of developing moderate acute malnutrition (MAM) in preschool mildly malnourished children. Children will be divided in two groups; one will received the cookie plus 12 educative sessions and the other just the educative program. The study will last 12 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedSeptember 27, 2018
September 1, 2018
2 years
September 29, 2015
September 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Weight (kg) for height (cm) Z-score
12 months
Secondary Outcomes (5)
Weight (kg) gains
12 months
height (cm) for age (months) Z-score
12 months
weight (kg) for age (months) Z-score
12 months
Mid-upper arm circumference (cm) (MUAC)
12 months
height (cm) gains
12 months
Study Arms (2)
Nutritional oats cookie and educational session
EXPERIMENTALNutritional cookie with oats and nuts
Educational session only
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- (2-5 years old), who are from low socioeconomic classes (E and D classes)
- reside in rural areas, and with WHZ- between \> -3 and ≤ -2, and
- informed consent given by the subject's mother or caregiver
You may not qualify if:
- Severe acute malnutrition (HAZ, WAZ and WHZ-scores ≤-3) based on the 2006 World Health Organization (WHO) reference values (24)
- Vitamin A deficiency (softening, ulceration, cloudiness of the cornea, and dryness of the conjunctivitis), and iodine deficiency (visible goiter)
- (3 or more episodes of loose/liquid stools/per day and lasted more than 24-hours), fever (high temperature that lasted more than 24 hours as reported by the mother/caregiver), and respiratory infections (coughing and/or runny nose that last more than 24 hours).
- Current consumption of other supplementary foods.
- Peanut or other ingredient allergy based on prior report. If some direct family member is allergic to peanuts, child would not be enrolled.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Un Kilo de Ayuda
Colonia Lomas de Chapultepec, Mexico City, 11000, Mexico
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Talavera, PhD
Universidad Autónoma del Estado de México
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 8, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
September 27, 2018
Record last verified: 2018-09