NCT04719052: MED4Youth

Mediterranean Enriched Diet for Tackling Youth Obesity

Completed NA Last updated 30 October 2024

What this trial tests

NA trial testing Diet and behavioural intervention in Obesity, Adolescent in 240 participants. Completed in 28 November 2023.

Timeline

25 May 2021

Primary endpoint
9 October 2023

28 November 2023

Quick facts

Lead sponsor	Fundació Eurecat
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	240
Start date	25 May 2021
Primary completion	9 October 2023
Estimated completion	28 November 2023
Sites	1 location across Spain

Drugs / interventions tested

• Diet and behavioural intervention
• Diet and behavioural intervention

Conditions studied

• Obesity, Adolescent — all drugs for Obesity, Adolescent →
• Lifestyle, Healthy — all drugs for Lifestyle, Healthy →
• Diet, Healthy — all drugs for Diet, Healthy →
• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →

Sponsor

Fundació Eurecat

Who can join

Adults 13 to 17, any sex, with Obesity, Adolescent or Lifestyle, Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Study Protocol of a Multicenter Randomized Controlled Trial to Tackle Obesity through a Mediterranean Diet vs. a Traditional Low-Fat Diet in Adolescents: The MED4Youth Study.
   Boqué N, Tarro L, Rosi A, Torrell H, et al · · 2021 · cited 5× · PMID 34062731 · DOI 10.3390/ijerph18094841