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A Mediterranean Intervention on Prediabetic Children (INTKIDMEDPRED)

P

Pilar Aparicio Martinez

Status

Completed

Conditions

Prediabetic State

Treatments

Other: KIDMED

Study type

Interventional

Funder types

Other

Identifiers

NCT05424107
251
2353

Details and patient eligibility

About

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).

Enrollment

254 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

254 participants in 1 patient group

Non-nutritional intervention
Experimental group
Description:
Children with a prediabetic status that followed up the sessions without nutritional intervention by a health care professional
Treatment:
Other: KIDMED

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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