"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"

Summary

The goal of this clinical trial is to evaluate the effect of a multifactorial lifestyle intervention combining Mediterranean diet, energy reduction and physical activity on weight loss in middle-aged adults (men and women 30-50 years old) with metabolic syndrome. The main questions it aims to answer are: Is a multifactorial intervention based on Mediterranean diet, energy reduction and physical activity able to promote weight loss maintenance in middle-aged men and women with metabolic syndrome? syndrome? Which are the sociodemographic barriers to adhere to a multifactorial lifestyle intervention to promote cardiometabolic health? How is the lifestyle pattern of middle-aged Spanish adults with metabolic Researchers will compare a multifactorial lifestyle intervention combining Mediterranean diet, energy reduction and physical activity to a control intervention based on usual primary healthcare to see if the intervention improve cardiometabolic traits and promote weight loss maintenance after 1 year. Participants in the intervention arm will be asked to follow an energy-reduced Mediterranean diet plus a physical activity program with the aim of reducing 5-10% of the initial weight in 6 months and of maintaining the weight lost after 1 year o follow-up.

Eligibility

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.

Conditions4

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