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

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

Study Overview

• Status: Completed
• Conditions: Moderate Acute Malnutrition (MAM)
• Intervention / Treatment: Other: Nutritional cookie

• Study Type: Interventional
• Enrollment (Actual): 1048
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Distrito Federal
    • Colonia Lomas De Chapultepec, Distrito Federal, Mexico, 11000
      • Un Kilo de Ayuda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nutritional oats cookie and educational session; Nutritional cookie with oats and nuts	Other: Nutritional cookie
No Intervention: Educational session only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight (kg) for height (cm) Z-score	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Juan Talavera, PhD, Universidad Autonoma del Estado de Mexico

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 25, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: PEP-1410