Trials Sponsors Conditions Drugs Pricing

Brief Summary

The prevalence of obesity is one of the main public health problems worldwide, reaching 18% among young people between 5 and 19 years of age in 2016. One possibility of effective treatment can be the Mediterranean diet (MD). Therefore, it is proposed to carry out a nutritional intervention based on this diet to more effectively reduce obesity in adolescents. The main purpose of this multicentre study is to assess whether an energy-restricted Mediterranean-style diet (MD) intervention including healthy products from the Mediterranean basin (mixed nuts, pomegranate and hummus) and sourdough bread is more effective against obesity and associated CVD risk factors than a conventional low-fat diet carrying out a multicentre nutritional and clinical intervention study specifically targeting obese/overweight adolescents (13-17y) from different Mediterranean countries; all combined with an educational web-application designed to encourage healthy behaviours. It is a multicenter, randomized, controlled intervention study conducted with adolescents with obesity/overweight ≥90 percentile who do not suffer from any chronic disease. 240 subjects will be recruited from three Mediterranean countries: Italy (Parma), Portugal (Coimbra) and Spain (Reus), specifically 80 participants per country, 40 adolescents as an intervention group and 40 as a control group, in Reus. The intervention study is scheduled to begin in January 2021. The intervention group will receive a diet based on the characteristics of MD, and will be reinforced with satisfying and healthy Mediterranean foods such as sourdough bread (2 servings of 50-60g / day), squeezed pomegranate (4 servings of 200ml / week), hummus/chickpeas (2 portions of chickpeas of 150-200g / week, one in hummus format) and mixed nuts (4 servings of 30g / week); and the control group will receive a recommended diet based on the consumption of low-fat foods. A caloric restriction of 20% of the total energy requirements will be applied to both groups in adolescents with BMI ≥95 percentile (obesity) and a caloric restriction \<20% of the total energy requirements will be applied in adolescents with BMI ≥90 to \<95th percentile according to overweight (gender/age / physical activity). The diet will be applied for 4 months in both groups. Adolescents from both groups will be given a motivational interview and will be provided with an educational website that will be used during the intervention, through which they will learn.

Conditions

Cardiovascular Risk Factor Diet, Healthy Lifestyle, Healthy Obesity, Adolescent

Keywords

Youth ObesityMediterranean dietInterventional studyHealthy lifestylesEducational approach

Outcome Measures

Primary Outcomes (1)

Change from baseline BMI z-score at 4 months and 8 months
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.
"4 months" and "4 months after study cessation"

Secondary Outcomes (18)

Change from baseline Adherence to the Mediterranean Diet at 4 and 8 months
"4 months" and "4 months after study cessation"
Change from baseline Level of physical activity at 4 and 8 months
"4 months" and "4 months after study cessation"

Study Arms (2)

Mediterranean diet group

EXPERIMENTAL

1\) The MD will be based on high consumption of unsaturated fat from vegetable sources (virgin olive oil and nuts) and minimally processed plant foods (vegetables, fruits, nuts, whole grains and legumes), low consumption of meat (especially red and processed meats) and sweets, and moderate consumption of fish and dairy products (mainly yoghurt and cheese). Accordingly, this diet will provide a high amount of mono and polyunsaturated fatty acids, fibre and phenolic compounds. Adolescents in the MD group will replace the intake of conventional breads by sourdough bread consumption (2 servings of 50-60 g daily) and incorporate into their diet chickpeas (2 servings of 150 g/week chickpeas, minimum one of them in hummus format), and they will consume at least another serving of legumes which can be chickpeas or another legume), pomegranate juice (4 servings of 200ml/week) and mixed nuts (4 servings of 30 g/week).

Other: Diet and behavioural intervention

Low-fat diet group

ACTIVE COMPARATOR

2\) The low-fat diet (control diet) will be based on low consumption of fats. A low-fat diet is the most used diet for obesity treatment in adolescents. This group will not receive any additional specific food by researchers. This diet will be based on the diet proposed as low-fat diet in the PREDIMED study

Interventions

Diet and behavioural interventionOther

Intervention will receive a specific diet designed following the characteristics of Mediterranean Diet

Also known as: MEDITERRANEAN DIET

Mediterranean diet group

Diet and behavioural interventionOther

Control group will receive a specific diet designed following the characteristics of Low fat Diet.

Eligibility Criteria

Age13 Years - 17 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

boys and girls aged 13-17 years
having obesity, defined as an age- and sex-specific BMI in the 95th percentile or greater (1), or great overweight (age- and sex-specific BMI in the ≥90th to \<95th percentile),

Sponsors & Collaborators

Hospital Universitari Sant Joan de Reus
Othercollaborator
University of Parma
Othercollaborator
Fundació Eurecat

Study Sites (1)

Eurecat

Reus, 43204, Spain

Related Publications (21)

Guideline: Assessing and Managing Children at Primary Health-Care Facilities to Prevent Overweight and Obesity in the Context of the Double Burden of Malnutrition: Updates for the Integrated Management of Childhood Illness (IMCI). Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK487902/
PMID: 29578661BACKGROUND
Miller AL, Lee HJ, Lumeng JC. Obesity-associated biomarkers and executive function in children. Pediatr Res. 2015 Jan;77(1-2):143-7. doi: 10.1038/pr.2014.158. Epub 2014 Oct 13.
PMID: 25310758BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Interventions

DietDiet, MediterraneanDiet, Fat-Restricted

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena

Study Officials

Antoni Caimari, PhD
Eurecat-Reus
PRINCIPAL INVESTIGATOR

Enrollment

240 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Masking Details: 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.
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of Eurecat's Biotechnology Area, Principal Investigator

Study Record Dates

First Submitted

January 14, 2021

First Posted

January 22, 2021

Mediterranean Enriched Diet for Tackling Youth Obesity

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (18)

Study Arms (2)

Mediterranean diet group

Low-fat diet group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Mediterranean Enriched Diet for Tackling Youth Obesity

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (18)

Study Arms (2)

Mediterranean diet group

Low-fat diet group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (21)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations