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

RecruitingNAAges 30 Years - 50 YearsAllIMDEA Food
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In plain words

What the trial is, and whether it could suit you

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 he

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program
  • Usual Care
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Where

1 site
IMDEA Nutrition
Madrid, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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