"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
IMDEA Food
106 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
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 Criteria4
- 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 Criteria14
- 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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Interventions
An intensive multifactorial lifestyle intervention involving monthly individual and group sessions during 6 months. Participants will be asked to follow a Mediterranean diet with a 25% reduction in energy and a physical activity program based on WHO recommendations to achieve a moderate physical activity level.
Participants in the control group will be asked to follow general recommendations to adhere to a healthy lifestyle, as indicated in the clinical guidelines of general practitioners and nurses for adults with metabolic syndrome
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06857929