Feeding for Accesible, Affordable and Healthy Childhood

Not Applicable

Completed

• Conditions: Healthy Children
• Interventions: Other: ALINFA; Other: Control

• Registration Number: NCT05249166
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-12-09
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Status Verified: 2022-01
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALINFA group	ALINFA	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.
Control group	Control	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

Primary Outcome Measures

Name	Time	Method
Dietary Pattern (questionnaire)	Baseline	Evaluate differences in dietary pattern between groups
Dietary pattern (questionnaire)	Baseline vs 8 week	Evaluated changes in dietary pattern

Trial Locations

Locations (1)

Center for Nutrition Research. University of Navarra; 🇪🇸 Pamplona, Navarra, Spain