Supplementary Food on Prevention of Moderate Malnutrition in Children

Not Applicable

Completed

• Conditions: Moderate Acute Malnutrition (MAM)
• Interventions: Other: Nutritional cookie

• Registration Number: NCT02572258
• Lead Sponsor: PepsiCo Global R&D

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1048

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional oats cookie and educational session	Nutritional cookie	Nutritional cookie with oats and nuts

Primary Outcome Measures

Name	Time	Method
Weight (kg) for height (cm) Z-score	12 months

Secondary Outcome Measures

Name	Time	Method
Weight (kg) gains	12 months
weight (kg) for age (months) Z-score	12 months
height (cm) for age (months) Z-score	12 months
Mid-upper arm circumference (cm) (MUAC)	12 months
height (cm) gains	12 months

Trial Locations

Locations (1)

Un Kilo de Ayuda; 🇲🇽 Colonia Lomas De Chapultepec, Distrito Federal, Mexico