Healthy
Conditions
Keywords
Physical activity, Food Habits, Information and communiation Technology, Health education
Brief summary
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.
Detailed description
* 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.
Interventions
OTHERIntervention group
Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition
Conseling on physical activity and nutrition (intervention)
Sponsors
Instituto de Salud Carlos III
Instituto de Investigación Biomédica de Salamanca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Obese subjects (IMC ≥ 27.5 to \<40), classified as sedentary according to the short physical activity questionnaire validated in the EVIDENT II study.
Exclusion criteria
* Older than 65 years are excluded, due to difficulties in the use of ICTs. * Advanced respiratory, renal or liver disease. * Several mental illness * Coronary or cerebrovascular atherosclerotic disease, grade II or higher NYHA heart failure. * Moderate or severe COPD * Muscular-skeletal pathology that inhibit mobility * Subjects who can not exercise or follow a hypocaloric diet. * Oncologic disease in treatment diagnosed in the last 5 years. * Terminal situation * Pregnancy * Bariatric surgery * Those with any other circumstance that the investigators consider could interfere with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight reduction | 1 year | Measurement by kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decrease sedestation minute week | 1 year | Minutes week in sedentary activity by Activpal monitor |
| Decrease total caloric intake/day | 1 year | Calories/day by Food frecuency questionnaire |
| Increase steps/day | 1 year | Steps/day by accelerometer |
| Augmentation index | 1 year | Central and peripheral augmentation index |
| Adiponectin | 1 year | Inflammation marker |
| Improve Quality of life | 1 year | Measurement by IWQOL-L |
Countries
Spain
Outcome results
None listed