Effectiveness to Weight Loss in Sedentary and Overweight People Using a Smartphone Application.

Study Overview
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Brief Summary
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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
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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.

Official Title
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EVIDENT3 Study: A Randomized, Controlled Clinical Trial to Reduce Inactivity and Caloric Intake in Sedentary, Overweight People Using a Smartphone Application. Study Protocol.

Conditions
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Healthy

Intervention / Treatment
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* Other: Intervention group
* Other: Control: Lifestyle counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control: Lifestyle counseling<br>Counseling on physical activity and nutrition. | Other: Control: Lifestyle counseling<br>* Conseling on physical activity and nutrition (intervention)<br>|
| Experimental: Intervention group<br>Add for three months a Smartphone with an app (EVIDENT III) and a Smartband to lose weight and improve physical activity. | Other: Intervention group<br>* Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition<br>Other: Control: Lifestyle counseling<br>* Conseling on physical activity and nutrition (intervention)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight reduction | Measurement by kilograms | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase steps/day | Steps/day by accelerometer | 1 year | 
| Decrease sedestation minute week | Minutes week in sedentary activity by Activpal monitor | 1 year | 
| Decrease total caloric intake/day | Calories/day by Food frecuency questionnaire | 1 year | 
| Improve Quality of life | Measurement by IWQOL-L | 1 year | 
| Augmentation index | Central and peripheral augmentation index | 1 year | 
| Adiponectin | Inflammation marker | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Food Habits, Information and communiation Technology, Health education