Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Supplementary Food on Prevention of Moderate Malnutrition in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572258
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Moderate Acute Malnutrition (MAM) Other: Nutritional cookie Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1048 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Supplementary Food Cookies on Prevention of Moderate Malnutrition in Preschool Children in Rural Mexico
Actual Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Nutritional oats cookie and educational session
Nutritional cookie with oats and nuts
Other: Nutritional cookie
No Intervention: Educational session only



Primary Outcome Measures :
  1. Weight (kg) for height (cm) Z-score [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Weight (kg) gains [ Time Frame: 12 months ]
  2. height (cm) for age (months) Z-score [ Time Frame: 12 months ]
  3. weight (kg) for age (months) Z-score [ Time Frame: 12 months ]
  4. Mid-upper arm circumference (cm) (MUAC) [ Time Frame: 12 months ]
  5. height (cm) gains [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572258


Locations
Layout table for location information
Mexico
Un Kilo de Ayuda
Colonia Lomas De Chapultepec, Distrito Federal, Mexico, 11000
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
Layout table for investigator information
Principal Investigator: Juan Talavera, PhD Universidad Autónoma del Estado de México
Layout table for additonal information
Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT02572258    
Other Study ID Numbers: PEP-1410
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Nutrition Disorders