Mediterranean Enriched Diet for Tackling Youth Obesity
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cardiovascular Risk Factor
- Diet, Healthy
- Lifestyle, Healthy
- Obesity, Adolescent
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A multicentre, blind, single-randomized, parallel, clinical trialMasking: Single (Investigator)Masking Description: Due to the nature of the study, the participants cannot be blinded to the intervention, although the investigators who will perform the sample and data analysis will be blinded.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 13 years and 17 years
- Gender
- Both males and females
Description
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups. The secondary outcomes are: Adherence ...
The principal outcome is BMI z-score, a standardized measure of BMI based on the specific age and gender norms. The effectiveness of the intervention will be evaluated by comparing the BMI z-score between the control (low-fat diet) and intervention (MD) groups. The secondary outcomes are: Adherence to the DM, KidMed questionnaire; Level of physical activity, PAQ-A questionnaire; Habit/food intake: 3-day dietary record, Helena study food frequency questionnaire, Knowledge about food and nutrition, a questionnaire from Helena's study; Quality of life, kid screen-27 Index; Sociodemographic data of the parents; Anthropometric data: weight, height, BMI, body composition, waist circumference, waist-hip ratio; Clinical variables: blood pressure, Biochemical variables and omic determinations: in urine, blood and feces. In total, the adolescents will receive 5 visits: 1 pre-selection visit (to check inclusion / exclusion criteria in the study) (V0) 1 inclusion visit (V1) in which stool, urine, and blood samples will be collected, anthropometric measurements (such as weight and waist circumference) and blood pressure will be taken, and questionnaires and records will be answered dietary. 1 follow-up visit (V2), at 2 months, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered. 1 final visit (V3), at 4 months, in which stool, urine, and blood samples will be collected, anthropometric and blood pressure measurements will be made, and questionnaires and dietary records will be answered. 1 post-intervention follow-up visit (V4), 4 months after the end of the intervention, in which anthropometric and blood pressure measurements will be taken and questionnaires and dietary records will be answered.
Tracking Information
- NCT #
- NCT04719052
- Collaborators
- University of Parma
- University of Coimbra
- Hospital Universitari Sant Joan de Reus
- Investigators
- Not Provided
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