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ALINFA: Feeding for Accesible, Affordable and Healthy Childhood

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra (Other)
Overall Status
Completed
CT.gov ID
NCT05249166
Collaborator
Universidad Pública de Navarra (Other), Gobierno de Navarra (Other)
70
Enrollment
1
Location
2
Arms
8.9
Actual Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ALINFA
  • Other: Control
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Feeding for Accesible, Affordable and Healthy Childhood
Actual Study Start Date :
Mar 15, 2021
Actual Primary Completion Date :
Dec 10, 2021
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dietary Pattern (questionnaire) [Baseline]

    Evaluate differences in dietary pattern between groups

  2. Dietary pattern (questionnaire) [8 week]

    Evaluate differences in dietary pattern between groups

  3. Dietary pattern (questionnaire) [Baseline vs 8 week]

    Evaluated changes in dietary pattern

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Nutrition Research. University of Navarra Pamplona Navarra Spain 31008

Sponsors and Collaborators

  • Clinica Universidad de Navarra, Universidad de Navarra
  • Universidad Pública de Navarra
  • Gobierno de Navarra

Investigators

  • Principal Investigator: Santiago Navas Carretero, PhD, University of Navarra

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT05249166
Other Study ID Numbers:
  • ALINFA
First Posted:
Feb 21, 2022
Last Update Posted:
Feb 21, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 21, 2022