Feeding for Accesible, Affordable and Healthy Childhood (ALINFA)

The main objective of this study was to evaluate the effectiveness of implementing a healthy eating vs traditional recommendations on the Medkid index of children in primary school. To do so, different companies involved in ALINFA project developed with the assessment of UNAV, CNTA and UPNA, a healthy bi-weekly menu.

Study Overview

• Status: Completed
• Conditions: Healthy Children
• Intervention / Treatment: Other: Control; Other: ALINFA

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Center for Nutrition Research. University of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adequate cultural level and comprehension of the clinical study from the legal tutors.
• To agree in taking part of the study.

Exclusion Criteria:

• Children presenting clinically relevant gastrointestinal malfunctions or structural anomalies, such as ulcers, chronic inflammatory diseases, etc. Even if they do not follow any pharmacological treatment at the moment of inclusion.
• Children with uncontrolled endocrine disorders.
• Children with any type of tumor/cancer within the last 5 years, or in current treatment.
• Children with any alimentary allergy.
• Children presenting any type of cognitive or psychic disorder
• Parents or legal tutors in which their future collaboration may not be the required, seen from the researchers' point of view.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control group; Subjects assigned to this arm will follow the habitual recommendations to develop skills for a healthy diet. No specific foods or cooking methods will be applied	Other: Control; control group
EXPERIMENTAL: ALINFA group; This group will receive, in addition to the usual recommendations, meals, and foods designed to increase the healthiness of the diet. Foods and meals have been designed to increase the fiber content, decrease sugars and saturated fats, and limit salt intake.	Other: ALINFA; Comparing the usual recommendations with the healthy diet designed and developed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary Pattern (questionnaire)	Evaluate differences in dietary pattern between groups	Baseline
Dietary pattern (questionnaire)	Evaluate differences in dietary pattern between groups	8 week
Dietary pattern (questionnaire)	Evaluated changes in dietary pattern	Baseline vs 8 week

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborators: Universidad Pública de Navarra; Gobierno de Navarra
• Investigators: Principal Investigator: Santiago Navas Carretero, PhD, University of Navarra

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2021
• Primary Completion (ACTUAL): December 10, 2021
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (ACTUAL): February 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: ALINFA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No