Calorie-reduced Mediterranean diet plus activity program to lower chronic disease risk in 30–50-year-olds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional program compares a multifactorial lifestyle intervention—an energy-reduced Mediterranean diet (about 25% caloric restriction) plus a structured physical activity program—to usual primary care in middle-aged adults with metabolic syndrome. Participants are men and women aged roughly 30–50 years with BMI 27–40 kg/m2 and stable recent weight, enrolled at IMDEA Nutrition in Madrid. The intervention is delivered within the primary care framework and targets weight loss maintenance, improvements in blood pressure, glucose, and lipid measures, and identification of sociodemographic barriers to adherence. Outcomes include weight change, cardiometabolic trait changes, adherence measures, and progression through stages of behavior change.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* BMI 27-40 Kg/m2
* Metabolic syndrome according to International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity
* Stable weight in the last 3 months (weight changes \< 4Kg)
* Be able to give informed consent

Exclusion Criteria:

* Have a diagnosed illness that interferes with the recommendations proposed in the intervention.
* Women with established menopause.
* Pregnant or breastfeeding women.
* Serious psychiatric illness/disorder.
* Social, cultural or psychological factors that may affect adherence to the intervention protocol.
* Inability to communicate with study staff.
* Inability to follow recommended diet or inability to engage in physical activity.
* Low likelihood of modifying dietary habits according to the different stages of change according to the Prochaska and DiClemente model.
* Difficulty attending scheduled appointments within the intervention due to work schedule conflicts, travel plans, scheduled surgeries, among other reasons.
* Therapeutic non-compliance.
* Participating in a professionally-led nutritional intervention.
* Being under medical treatment that affects weight, intake or energy expenditure in the 3 months preceding the start of the study.

Smokers who have changed their smoking habit in the 6 months preceding the start of the study (including starting or stopping smoking).

\- Participation in another trial that may interfere with this proposed study.

Where it's running

• IMDEA Nutrition
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Lidia Daimiel Ruiz, Senior Researcher — IMDEA Food
• Study coordinator: Lidia Daimiel Ruiz, Senior Researcher
• Email: lidia.daimiel@alimentacion.imdea.org
• Phone: +34917278100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.