Smartphone Applications to Improve Lifestyles in Olders Over 65 Years (EVIDENT-Age)

November 13, 2022 updated by: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Effectiveness of the Combined Use of Smartphone and Smartband Technology in the Improvement of Lifestyles in the Adult Population Over 65 Years of Age. Randomized Clinical Trial. EVIDENT Age Study

This is a randomized controlled clinical trial performed in urban primary care centers in Salamanca (Spain). Its objective is to evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age in the improvement of lifestyles, body composition, quality of life, cognitive performance and daily life activities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Objective: To evaluate the effect of an intervention based on the use of new information and communication technologies in a population of people over 65 years of age.
  • Design and setting: A randomized clinical trial of two parallel groups. Population: 140 participants over 65 years of age will be included, selected by consecutive sampling in primary care centers of Salamanca (Spain.
  • Measurements and intervention: Lifestyles (physical activity, sedentarism and mediterranean diet), body composition, health-related quality of life, cognitive performance and daily life activities will be evaluated at 3 months. The advice on healthy diet and physical activity recommendations will be common to both groups. The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.

Study Type

Interventional

Enrollment (Actual)

140

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, 37003
        • Instituto Biosanitario de Salamanca. Research unit La Alamedilla

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

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent signed
  • Age between 65 and 80 years

Exclusion Criteria:

  • Cardiovascular disease
  • Moderate or severe chronic obstructive pulmonary disease.
  • Musculoskeletal disease that limits ambulation.
  • Severe mental illness
  • Score in the Mini-mental <24 points.
  • Oncological disease in treatment.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Advice on healthy diet and physical activity recommendations
Behavioral: Control (Advice on healthy diet and physical activity recommendations)
Advice on healthy diet and physical activity recommendations
Experimental: Intervention
  • Advice on healthy diet and physical activity recommendations
  • Training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.
Behavioral: Control (Advice on healthy diet and physical activity recommendations)
Advice on healthy diet and physical activity recommendations
Behavioral: Intervention (training in use of a Smartphone application)
The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 3 months
Measurement by accelerometer (steps/day)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: 3 months
Measurement by Body fat percentage (%)
3 months
Cognitive performance
Time Frame: 3 months
Measurement by MINI MENTAL STATE EXAMINATION (Score between 0 (Cognitive impairment) and 30 (normal))
3 months
Improve Quality of life
Time Frame: 3 months
Measurement by the WHOQOL-AGE scale (Score between 13 (poor quality) and 65 (high quality))
3 months
Daily life activities
Time Frame: 3 months
Measurement by PFEFFER FUNCTIONAL ACTIVITY Questionnaire (Score between 0 (normal) and 33 (Functional alteration))
3 months
Sedentarism
Time Frame: 3 months
Measurement by Marshall questionnaire (sitting time - hours/day)
3 months
Adherence to the Mediterranean Diet
Time Frame: 3 months
Measurement by the MEDAS scale (Score between 0 (poor adherence) and 14 (high adherence))
3 months

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 Investigación Biomédica de Salamanca

Investigators

  • Principal Investigator: Jose I Recio-Rodriguez, PhD, University of Salamanca

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)

September 5, 2018

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria

June 29, 2018

First Posted (Actual)

July 2, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 13, 2022

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • YB17/00003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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