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CompletedNCT03175614EVIDENT3Updated May 31, 2024

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

An interventional study of Intervention group and Control: Lifestyle counseling in Healthy, sponsored by Instituto de Investigación Biomédica de Salamanca. Completed at 1 site in Spain. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Instituto de Investigación Biomédica de Salamanca · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
650
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Healthy

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Keywords

  • Physical activity
  • Food Habits
  • Information and communiation Technology
  • Health education
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 850 are open to participants now.

This study's enrollment of 650 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Instituto de Investigación Biomédica de Salamanca is the lead sponsor of 20 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
650 participants (actual)

Study arms

  • Active comparator
    Control: Lifestyle counseling

    Counseling on physical activity and nutrition.

    Other: Control: Lifestyle counseling

  • 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: Intervention group · Other: Control: Lifestyle counseling

Interventions

  • OtherIntervention group

    Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition

  • OtherControl: Lifestyle counseling

    Conseling on physical activity and nutrition (intervention)

06

What researchers measure

Primary outcomes

  1. Weight reduction

    Measurement by kilograms

    Time frame: 1 year

Secondary outcomes

  1. Increase steps/day

    Steps/day by accelerometer

    Time frame: 1 year

  2. Decrease sedestation minute week

    Minutes week in sedentary activity by Activpal monitor

    Time frame: 1 year

  3. Decrease total caloric intake/day

    Calories/day by Food frecuency questionnaire

    Time frame: 1 year

  4. Improve Quality of life

    Measurement by IWQOL-L

    Time frame: 1 year

  5. Augmentation index

    Central and peripheral augmentation index

    Time frame: 1 year

  6. Adiponectin

    Inflammation marker

    Time frame: 1 year

07

Study locations

1 site
  • Primary Care Research Unit - The Alamedilla Center for Health
    Salamanca, 37006, Spain
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References and documents

Publications

  • Lugones-Sanchez C, Recio-Rodriguez JI, Agudo-Conde C, Repiso-Gento I, G Adalia E, Ramirez-Manent JI, Sanchez-Calavera MA, Rodriguez-Sanchez E, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT 3 Investigators. Long-term Effectiveness of a Smartphone App Combined With a Smart Band on Weight Loss, Physical Activity, and Caloric Intake in a Population With Overweight and Obesity (Evident 3 Study): Randomized Controlled Trial. J Med Internet Res. 2022 Feb 1;24(2):e30416. doi: 10.2196/30416. PubMed 35103609 ↗
  • Lugones-Sanchez C, Recio-Rodriguez JI, Menendez-Suarez M, Saz-Lara A, Ramirez-Manent JI, Sanchez-Calavera MA, Gomez-Sanchez L, Rodriguez-Sanchez E, Garcia-Ortiz L, Evident Investigators Group. Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3. Nutrients. 2022 Jan 9;14(2):270. doi: 10.3390/nu14020270. PubMed 35057451 ↗
  • Lugones-Sanchez C, Sanchez-Calavera MA, Repiso-Gento I, Adalia EG, Ramirez-Manent JI, Agudo-Conde C, Rodriguez-Sanchez E, Gomez-Marcos MA, Recio-Rodriguez JI, Garcia-Ortiz L; EVIDENT 3 Investigators. Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study). JMIR Mhealth Uhealth. 2020 Nov 26;8(11):e21771. doi: 10.2196/21771. PubMed 33242020 ↗
  • Recio-Rodriguez JI, Gomez-Marcos MA, Agudo-Conde C, Ramirez I, Gonzalez-Viejo N, Gomez-Arranz A, Salcedo-Aguilar F, Rodriguez-Sanchez E, Alonso-Dominguez R, Sanchez-Aguadero N, Gonzalez-Sanchez J, Garcia-Ortiz L; EVIDENT 3 investigators. EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application: Study protocol. Medicine (Baltimore). 2018 Jan;97(2):e9633. doi: 10.1097/MD.0000000000009633. PubMed 29480874 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03175614
Lead sponsor
Instituto de Investigación Biomédica de Salamanca
Collaborators
Instituto de Salud Carlos III
Responsible party
Sponsor
First posted
Jun 5, 2017
Start date
Jun 1, 2017
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
May 31, 2024

Study contacts

Luis Garcia Ortiz, MD, PhD
principal investigator · Fundacion Infosalud

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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