Effectiveness to Weight Loss in Sedentary and Overweight People Using a Smartphone Application. (EVIDENT3)

March 1, 2021 updated by: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37006
        • Primary Care Research Unit - The Alamedilla Center for Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Luis Garcia Ortiz, MD, PhD, FUNDACION INFOSALUD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

May 31, 2017

First Submitted That Met QC Criteria

June 1, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI16/00101
  • PI16/00170 (Other Grant/Funding Number: Instituto de San Carlos III)
  • GRS 1277/B/16 (Other Grant/Funding Number: Gerencia Regional de Salud de Castilla y León)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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