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

Recruiting · NCT06857929 · Interventional (participants receive a specific treatment) · Lead sponsor: IMDEA Food

View the official record on ClinicalTrials.gov →

Interventions studied

Usual Careenergy reduced Mediterranean diet (25% caloric restriction) plus physical activity program

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.

Who can take part

Age range

30 Years to 50 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

IMDEA Nutrition - Madrid, Madrid, Spain

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →