Please select the eligibility criteria that correspond to the clinical trial below.
Title: School-based Behavioural Intervention to Face Obesity and Promote Cardiovascular Health Among Spanish Adolescents: a Cluster-randomized Controlled Trial
Brief Summary: Background and objective:

There is an alarming increase in obesity and unhealthy lifestyles in adolescents. This issue threatens to have a highly negative health and socioeconomic impact in the near future. The only way to tackle this epidemic is to implement effective preventive strategies able to positively impact on youth lifestyle behaviours. The school is the most appropriate environment for such an intervention. The main objective of this study is to evaluate the efficacy of a comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles. The project consortium constitutes a unique framework of research groups at the forefront of novel and successful approaches aiming to healthier behaviours and dietary habits.

Methodology:

A cluster-randomized controlled trial involving 24 secondary schools in Spain will be carried out. Schools will be 1:1:1 randomized to receive a short-term (2-year) or a long-term (4-year) comprehensive educational program, or to receive the usual curriculum (control). Participants will be evaluated at baseline, and after 2 and 4 years with the following: weight scale, circumference measuring tape, bioelectrical impedance, dual energy X-ray absorptiometry, sphygmomanometer, blood analysis, saliva and urine analysis, accelerometers, and questionnaires. The primary outcome is the change in obesity and other health parameters from baseline to year 2 and 4, as assessed by the Ideal Cardiovascular Health score. Secondary outcomes include the change in adiposity, anthropometry and body composition parameters, physical activity and dietary habits, polyphenol and carotenoid intake, metabolomics and attitudes. Participants will be measured again when they reach 20 years old.

Expected results:

The investigators expects to show that a school-based educational intervention induces favorable lifestyle changes and improves cardiovascular health among Spanish adolescents, including obesity/adiposity and metabolic profiles. If successful, this strategy could be widely adopted having a meaningful effect on obesity and cardiovascular health promotion. Additionally, associations between health parameters and bioactive dietary compounds intake and metabolic profiles will be stablished.


Options:
A: Inclusion Criteria:

* • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.

Exclusion Criteria:

* No exclusion criteria.
B: Inclusion Criteria:

* Minimum age of 11 years old
* Reside in a household with at least one adult and one child (11-18)
* Not planning to move from the area over the next two years
* Willing and able to participate in all aspects of the study
* Willingness to provide oral informed consent
* Hispanic, Sudanese, Somali
* Residing in Rochester, MN

Exclusion Criteria:

* Self-reported pregnancy
* Self-reported insulin-dependent diabetes
* Self-reported diagnosis of cancer within the past 3 years
* Answer of "yes" to the following question: "Do you know of any reason why you should not do physical activity? For example, would it be unsafe for you to do increased physical activity because of a health problem?"
C: Inclusion Criteria:

* Enrolled in the 6th or 7th grade at the target school.
* Parent consent and child assent to participate.

Exclusion Criteria:

* Taking medications for weight control.
D: Inclusion criteria

* Attending grade 9 or 10 in one of the 35 state-run school of the Vosges department and be in a general, technological or vocational course,
* Aged ≤ 18 years old,
* not giving written refusal to participate in the trial,
* able to complete a questionnaire,
* overweight or obese according to the IOTF criteria (for BMI) and the McCarthy criteria (for waist circumference) and/or have a high eating disorder score, and/or express the need for management of excess weight,
* confirmed as corresponding to the 4 previous inclusion criteria by the physician, with elimination of adolescents with false-positive BMI (particularly athletic adolescents),
* agree to an overweight and obesity care management program.

Answer: A