Feeding for Accesible, Affordable and Healthy Childhood

NCT ID: NCT05249166

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2021-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

control group

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.

Group Type EXPERIMENTAL

ALINFA

Intervention Type OTHER

Comparing the usual recommendations with the healthy diet designed and developed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALINFA

Comparing the usual recommendations with the healthy diet designed and developed

Intervention Type OTHER

Control

control group

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Pública de Navarra

OTHER

Sponsor Role collaborator

Gobierno de Navarra

UNKNOWN

Sponsor Role collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Santiago Navas Carretero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Navarra

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Nutrition Research. University of Navarra

Pamplona, Navarre, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALINFA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.