Feeding for Accesible, Affordable and Healthy Childhood

NCT05249166 | Completed

• 1 other identifier: ALINFA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Children

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

ALINFA group

EXPERIMENTAL

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

Interventions

ALINFA OTHER

Comparing the usual recommendations with the healthy diet designed and developed

ALINFA group

Control OTHER

control group

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Universidad Pública de Navarra: collaborator
• Gobierno de Navarra: collaborator

Study Sites (1)

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Study Officials

• Santiago Navas Carretero, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: February 21, 2022
• Study Start: March 15, 2021
• Primary Completion: December 10, 2021
• Study Completion: December 10, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-01

Locations

ES (1)