Clinical trial NCT05424107: A Mediterranean Intervention on Prediabetic Children
Official title: Nutritional Status of South Spanish Children: A Mediterranean Diet Nutritional Intervention of Children With Insulin Resistance From a Rural Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: Nutritional intervention
Prediabetes
Children
Mediterranean diet
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
Collaborators: name: Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC)
First posted: 2022-06-21
Enrollment: 254
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: HbA1c levels
timeFrame: Up to six months
Secondary outcomes:
measure: Height (m2)
timeFrame: Up to six months
measure: Weight (kg)
timeFrame: Up to six months
measure: Waist circumference (cm)
timeFrame: Up to six months
measure: Hip circumference(cm)
timeFrame: Up to six months
measure: Arm circumference (cm)
timeFrame: Up to six months
measure: Body mass index (kg/m2)
timeFrame: Up to six months
measure: Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)
timeFrame: Up to six months
measure: The Food Frequency Questionnaire (FFQ)
timeFrame: Up to six months
measure: Decalogue of healthy eating
timeFrame: Up to six months
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Ayuntamiento de Pedra Abad
Study officials:
affiliation: Maimónides Biomedical Research Institute of Córdoba
name: Francisco Javier Fonseca del Pozo, PhD
role: PRINCIPAL_INVESTIGATOR
References: