Actively Recruiting
Nutritional Approach for the Transformation and Reduction of Chronic Disease Indicators in Middle-aged Adults at High Risk
Led by IMDEA Food · Updated on 2026-03-27
106
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a multifactorial lifestyle intervention involving a Mediterranean diet with reduced calories and increased physical activity can help middle-aged adults (30-50 years) with metabolic syndrome lose weight and maintain that weight loss over time. The study also aims to understand the social and demographic challenges people face in sticking to these healthy habits and to examine the lifestyle patterns of this group. Participants will be randomly assigned to one of two groups. One group will follow general lifestyle recommendations from primary healthcare providers, while the other will receive an intensive program that includes monthly individual and group sessions over 6 months to encourage a Mediterranean diet with 25% fewer calories and physical activity based on WHO guidelines. The goal for the intervention group is to reduce their initial weight by 5-10% within 6 months and maintain this loss after 12 months. Throughout the study, participants will undergo assessments including measurements of weight, waist size, blood sugar, triglycerides, and glycated hemoglobin to monitor changes in their health. Data on demographics, diet, clinical parameters, and laboratory tests will be collected. After the 6-month intervention, a follow-up at 12 months will evaluate how well participants maintain their lifestyle changes. The study emphasizes tracking adherence and identifying factors that help or hinder long-term weight loss maintenance.
CONDITIONS
Brief Title
"Improving Health and Reducing Chronic Disease Risk in Middle-Aged Adults Through Nutrition"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 30 to 50 years
- Body mass index (BMI) between 27 and 40 kg/m2
- Diagnosed with metabolic syndrome according to established international criteria
- Stable weight in the last 3 months with less than 4 kg change
- Able to provide informed consent
You will not qualify if you...
- Diagnosed illness interfering with intervention recommendations
- Women who have undergone 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 the recommended diet or engage in physical activity
- Low likelihood of modifying dietary habits based on behavior change stages
- Difficulty attending scheduled appointments due to work, travel, or surgery
- Therapeutic non-compliance
- Participation in another professionally-led nutritional intervention
- Medical treatment affecting weight, intake, or energy expenditure within 3 months before study
- Recent changes in smoking habits within 6 months before study
- Participation in another trial that may interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants in the intervention group follow an energy-reduced Mediterranean diet and a physical activity program aimed at losing 5-10% of their initial weight over 6 months. The control group follows general lifestyle recommendations for metabolic syndrome.
Monthly individual and group sessions for intervention group; control group follow-up visits as per clinical guidelines
Duration - 6 months
Participants are evaluated 6 months after completing the intervention to assess adherence to the therapeutic plan and maintenance of lifestyle changes.
1 follow-up visit at 12 months from baseline
Trial Site Locations
Total: 1 location
1
IMDEA Nutrition
Madrid, Madrid, Spain, 28049
Actively Recruiting
Research Team
L
Lidia Daimiel Ruiz, Senior Researcher
L
Laura Villanova, Predoctoral researcher
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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