A Mediterranean Intervention on Prediabetic Children

NCT05424107 | Completed DMC

• 2 other identifiers: 2353251
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prediabetic State

Keywords

Nutritional intervention; Prediabetes; Children; Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• HbA1c levels

  The HbA1c were measured at the initial visit (V0) and during the last visit (V4)

  Up to six months

Secondary Outcomes (9)

• Height (m2)

  Up to six months

• Weight (kg)

  Up to six months

• Waist circumference (cm)

  Up to six months

• Hip circumference(cm)

  Up to six months

• Arm circumference (cm)

  Up to six months

Study Arms (1)

Non-nutritional intervention

EXPERIMENTAL

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

Other: KIDMED

Interventions

KIDMED 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.

Non-nutritional intervention

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pilar Aparicio Martinez: lead
• Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC): collaborator

Study Sites (1)

Ayuntamiento de Pedra Abad

Córdoba, Spain

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Francisco Javier Fonseca del Pozo, PhD

  Maimónides Biomedical Research Institute of Córdoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher and Lecture at the University and IMIBIC

Model Details: 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).

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 21, 2022
• Study Start: September 4, 2018
• Primary Completion: January 4, 2020
• Study Completion: June 10, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

ES (1)