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HealthyEVIDENT3NCT03175614

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

A study testing Intervention group in people with Healthy, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Intervention group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
1 siteSpain
Study dates
1 Jun 2017to 30 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Obese subjects (IMC ≥ 27.5 to <40), classified as sedentary according to the short physical activity questionnaire validated in the EVIDENT II study.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Primary Care Research Unit - The Alamedilla Center for Health

    Salamanca, 37006

Other trials in Spain

About this study

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.

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.
Conditions
Healthy
Being tested
Intervention group, Control: Lifestyle counseling
Keywords
Physical activity, Food Habits, Information and communiation Technology, Health education
Medical subject headings
Motor Activity, Feeding Behavior, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention groupOther

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

  • Control: Lifestyle counselingOther

    Conseling on physical activity and nutrition (intervention)

Study groups in NCT03175614
Study groupRoleWhat they receive
Control: Lifestyle counselingActive comparatorCounseling on physical activity and nutrition.
Receives: Other: Control: Lifestyle counseling
Intervention groupExperimentalAdd for three months a Smartphone with an app (EVIDENT III) and a Smartband to lose weight and improve physical activity.
Receives: Other: Intervention group; Other: Control: Lifestyle counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight reduction

    Measurement by kilograms

    Measured: 1 year

Secondary outcomes (6)

  1. Increase steps/day

    Steps/day by accelerometer

    Measured: 1 year

  2. Decrease sedestation minute week

    Minutes week in sedentary activity by Activpal monitor

    Measured: 1 year

  3. Decrease total caloric intake/day

    Calories/day by Food frecuency questionnaire

    Measured: 1 year

  4. Improve Quality of life

    Measurement by IWQOL-L

    Measured: 1 year

  5. Augmentation index

    Central and peripheral augmentation index

    Measured: 1 year

  6. Adiponectin

    Inflammation marker

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start1 Jun 2017
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03175614
Sponsor's protocol ID
PI16/00101
Other IDs
PI16/00170, GRS 1277/B/16
Acronym
EVIDENT3
Status last verified
Mar 2021
First submitted
31 May 2017
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group in people with Healthy, run by Instituto de Investigación Biomédica de Salamanca at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight reduction (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03175614, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.

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