NCT03175614

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (actual)
• Sponsor: Instituto de Investigación Biomédica de Salamanca · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Intervention group	Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition
OTHER	Control: Lifestyle counseling	Conseling on physical activity and nutrition (intervention)

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2017-06-05
• Last updated: 2024-05-31

Locations

1 site across 1 country: Spain