This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the effects of the addition of an ICT tool developed for the Smartphone application and a Smartband in support of behavioral and educational recommendations to reduce weight.
* Objetive: To develop and validate an application for the use in Smartphone in which the management of a SmartBand is included and evaluate the effect of adding this tool of information and communication technology (ICT), to a standardized intervention reduce weight, reduce sedestation time, increase physical activity and decrease total caloric intake in obese and sedentary subjects. * Design and setting: A clinical of two parallel group, multicenter, randomized, aimed at assessing the effects of adding an ICT tool (intervention) to support behavioral and educational recommendations (control) in physical activity and weigh loss. Population: 700 obese and sedentary subjects will be included, 20 to 65 aged, selected by random sampling in 5 centers. * Measurements and intervention: physical and sedeentary acivity will be assessed with an accelometer and IPAQ and Marshall Questionnaires, the nutrition by a food frequency and adherence to the Mediterranean diet survey and weight loss with body mass index and waist circumference. Vascular function with a wrist-worn tonometer (blood pressure, augmentation index and pulse rate) will be evaluated and also the Cardio Ankle Vascular Index and carotid intima media thickness. The advice on nutrition (plate method) and exercise will be common to both groups. The intervention group will be added a training for 3 months in use of ICT tool described, designed to foment a healthy and low-calorie diet and increased physical acivity and decreased sedentary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
650
Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition
Conseling on physical activity and nutrition (intervention)
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, Spain
Weight reduction
Measurement by kilograms
Time frame: 1 year
Increase steps/day
Steps/day by accelerometer
Time frame: 1 year
Decrease sedestation minute week
Minutes week in sedentary activity by Activpal monitor
Time frame: 1 year
Decrease total caloric intake/day
Calories/day by Food frecuency questionnaire
Time frame: 1 year
Improve Quality of life
Measurement by IWQOL-L
Time frame: 1 year
Augmentation index
Central and peripheral augmentation index
Time frame: 1 year
Adiponectin
Inflammation marker
Time frame: 1 year
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