Actively Recruiting
"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Led by IMDEA Food · Updated on 2026-03-27
106
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI 27-40 Kg/m2
- Diagnosis of metabolic syndrome by recognized international criteria
- Stable weight in the last 3 months with less than 4 Kg change
- Ability to provide informed consent
- Age between 30 and 50 years
You will not qualify if you...
- Diagnosed illness interfering with intervention recommendations
- Women with established menopause
- Pregnant or breastfeeding women
- Serious psychiatric illness or disorder
- Social, cultural, or psychological factors affecting adherence
- Inability to communicate with study staff
- Inability to follow recommended diet or physical activity
- Low likelihood of changing dietary habits per Prochaska and DiClemente model
- Difficulty attending scheduled appointments due to work, travel, surgery, or other reasons
- Therapeutic non-compliance
- Participation in a professionally-led nutritional intervention
- Medical treatment affecting weight, intake, or energy expenditure in past 3 months
- Recent changes in smoking habits within 6 months
- Participation in another interfering clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
IMDEA Nutrition
Madrid, Madrid, Spain, 28049
Actively Recruiting
Research Team
L
Lidia Daimiel Ruiz, Senior Researcher
CONTACT
L
Laura Villanova, Predoctoral researcher
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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