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

Healthy Clinical Trial

— EVIDENT3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175614
• Other study ID #: PI16/00101
• Secondary ID: PI16/00170GRS 12
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2021
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Overweight

Intervention

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

Locations

Country	Name	City	State
Spain	Primary Care Research Unit - The Alamedilla Center for Health	Salamanca

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight reduction	Measurement by kilograms	1 year
Secondary	Increase steps/day	Steps/day by accelerometer	1 year
Secondary	Decrease sedestation minute week	Minutes week in sedentary activity by Activpal monitor	1 year
Secondary	Decrease total caloric intake/day	Calories/day by Food frecuency questionnaire	1 year
Secondary	Improve Quality of life	Measurement by IWQOL-L	1 year
Secondary	Augmentation index	Central and peripheral augmentation index	1 year
Secondary	Adiponectin	Inflammation marker	1 year