Nutritional Status of South Spanish Children: A Mediterranean Diet Nutritional Intervention of Children With Insulin Resistance From a Rural Area
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 254
- Locations
- 1
- Primary Endpoint
- HbA1c levels
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
HbA1c levels
Time Frame: Up to six months
The HbA1c were measured at the initial visit (V0) and during the last visit (V4)
Secondary Outcomes
- Height (m2)(Up to six months)
- Weight (kg)(Up to six months)
- Waist circumference (cm)(Up to six months)
- The Food Frequency Questionnaire (FFQ)(Up to six months)
- Body mass index (kg/m2)(Up to six months)
- Hip circumference(cm)(Up to six months)
- Arm circumference (cm)(Up to six months)
- Validated nutritional assessment questionnaire: adherence to the Mediterranean diet (KIDMED)(Up to six months)
- Decalogue of healthy eating(Up to six months)
Investigators
Pilar Aparicio Martinez
Researcher and Lecture at the University and IMIBIC
Universidad de Córdoba