Effectiveness to Weight Loss in Sedentary and Overweight People Using a Smartphone Application.
EVIDENT3
EVIDENT3 Study: A Randomized, Controlled Clinical Trial to Reduce Inactivity and Caloric Intake in Sedentary, Overweight People Using a Smartphone Application. Study Protocol.
3 other identifiers
interventional
650
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jun 2017
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMay 31, 2024
March 1, 2021
3.1 years
May 31, 2017
May 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight reduction
Measurement by kilograms
1 year
Secondary Outcomes (6)
Increase steps/day
1 year
Decrease sedestation minute week
1 year
Decrease total caloric intake/day
1 year
Improve Quality of life
1 year
Augmentation index
1 year
- +1 more secondary outcomes
Study Arms (2)
Control: Lifestyle counseling
ACTIVE COMPARATORCounseling on physical activity and nutrition.
Intervention group
EXPERIMENTALAdd for three months a Smartphone with an app (EVIDENT III) and a Smartband to lose weight and improve physical activity.
Interventions
Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition
Conseling on physical activity and nutrition (intervention)
Eligibility Criteria
You may qualify if:
- Obese subjects (IMC ≥ 27.5 to \<40), classified as sedentary according to the short physical activity questionnaire validated in the EVIDENT II study.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Primary Care Research Unit - The Alamedilla Center for Health
Salamanca, 37006, Spain
Related Publications (4)
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.
PMID: 35103609DERIVEDLugones-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.
PMID: 35057451DERIVEDLugones-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.
PMID: 33242020DERIVEDRecio-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.
PMID: 29480874DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Garcia Ortiz, MD, PhD
Fundacion Infosalud
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2017
First Posted
June 5, 2017
Study Start
June 1, 2017
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
May 31, 2024
Record last verified: 2021-03