Clinical trial NCT03574480: Smartphone Applications to Improve Lifestyles in Olders Over 65 Years
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Keywords: mHealth
Lifestyles
Elderly
Body composition
Cognitive performance
Quality of life
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2018-07-02
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity
timeFrame: 3 months
Secondary outcomes:
measure: Body composition
timeFrame: 3 months
measure: Cognitive performance
timeFrame: 3 months
measure: Improve Quality of life
timeFrame: 3 months
measure: Daily life activities
timeFrame: 3 months
measure: Sedentarism
timeFrame: 3 months
measure: Adherence to the Mediterranean Diet
timeFrame: 3 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Instituto Biosanitario de Salamanca. Research Unit La Alamedilla
Study officials:
affiliation: University of Salamanca
name: Jose I Recio-Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Recio-Rodriguez JI, Gonzalez-Sanchez S, Tamayo-Morales O, Gomez-Marcos MA, Garcia-Ortiz L, Nino-Martin V, Lugones-Sanchez C, Rodriguez-Sanchez E. Changes in lifestyles, cognitive impairment, quality of life and activity day living after combined use of smartphone and smartband technology: a randomized clinical trial (EVIDENT-Age study). BMC Geriatr. 2022 Oct 6;22(1):782. doi: 10.1186/s12877-022-03487-5.
citation: Recio-Rodriguez JI, Lugones-Sanchez C, Agudo-Conde C, Gonzalez-Sanchez J, Tamayo-Morales O, Gonzalez-Sanchez S, Fernandez-Alonso C, Maderuelo-Fernandez JA, Mora-Simon S, Gomez-Marcos MA, Rodriguez-Sanchez E, Garcia-Ortiz L. Combined use of smartphone and smartband technology in the improvement of lifestyles in the adult population over 65 years: study protocol for a randomized clinical trial (EVIDENT-Age study). BMC Geriatr. 2019 Jan 23;19(1):19. doi: 10.1186/s12877-019-1037-y.