A Mediterranean Intervention on Prediabetic Children

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2022-06-10

Brief Summary

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Prediabetes is a pathological condition where the blood glucose concentration is higher than normal concentrations but lower than those considered in type 2 diabetes mellitus (DM2) diagnosis. Until a few years ago, this prediabetes occurred in adults with associated risk factors such as being overweight or obese, sedentary lifestyle, poor eating habits, and cardiovascular problems, among others. Recently, it has begun to be detected in children, with family eating habits becoming more critical. Therefore, the objectives of this study were to determine the efficacy of the nutritional intervention in children with analytical data on pre-diabetes; and the secondary ones proposed were to evaluate if an individualized and directed nutritional intervention compared to the standardized one supposes an improvement in children's dietary habits and to determine if nutritional education improves anthropometric parameters and adherence to a Mediterranean diet, through the evaluation of the Mediterranean Diet Quality Index (KIDMED).

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Detailed Description

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Conditions

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Prediabetic State

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a study with pre-and post-intervention evaluation, randomized intervention in parallel groups EG and CG, in schoolchildren with analytical data of pre-diabetes. The study design was divided into two phases. In each phase, a follow-up was carried out with five visits, from the initial visit (v0) to the final visit (v4).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Non-nutritional intervention

Children with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional

Group Type EXPERIMENTAL

KIDMED

Intervention Type OTHER

Pre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values.

Interventions

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KIDMED

Pre-and post-intervention evaluation of the adherence to the Mediterranean diet and its effect on prediabetic state, as well as, other anthropometric values.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Presence of HbA1c levels between 5.7 and 6.4% in the blood tests
* Signed informed consent by the minor
* Signed informed consent by the minor's parents or guardians.

Exclusion Criteria

* Presence of HbA1c levels below 5.7%
* Presence of HbA1c levels above 6.4%
* Presence of pathological metabolic diseases, such as diabetes or metabolic syndrome
* Lack of the signed informed consent by the minor and legal guardian

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No