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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorIMDEA Food

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

106 Participants
are divided into 2 treatment groups

Sponsors and collaborators