"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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
energy reduced Mediterranean diet (25% caloric restriction) plus physical activity program
BehavioralAn 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.
Usual Care
BehavioralParticipants 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
Treatment groups
106 Participants
are divided into 2 treatment groupsGroup A: Control group (CG)Active comparator 1 intervention
Group B: Intervention Group (IG)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of weight loss
Weight loss measured as % from baseline weight with a calibrated scale
Time frame
6 months2
Percentage of weight loss maintenance
Percentage of weight loss maintained after 1 year, measured by a calibrated scale
Time frame
12 monthsSecondary outcomes
1
Change in waist perimeter (cm)
Waist circumference change (cm) after 6 months, measured at the midpoint between the last rib and the iliac crest using a flexible tap
Time frame
6 months2
Changes in tryglyceride level
Changes in trlyglycerides (mg/dL) after 6 months, measured from an overnight fasting blood with standard analyticial methods
Time frame
6 months3
Changes in fasting glucose levels
Changes in glucose levels (mg/dL), measured from blood collected after an overnight fast using standard analytical methods
Time frame
6 months4
Changes in glycated hemoglobin
Changes in % of glycated hemoglobin, measured from blood collected after and overnight fast, by standard methods
Time frame
6 months Source ClinicalTrials.gov