Smartphone Applications to Improve Lifestyles in Olders Over 65 Years

NCT ID: NCT03574480

Last Updated: 2022-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-05

Study Completion Date

2020-09-30

Brief Summary

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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

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* 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.

Conditions

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Telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Control

Advice on healthy diet and physical activity recommendations

Group Type EXPERIMENTAL

Control (Advice on healthy diet and physical activity recommendations)

Intervention Type BEHAVIORAL

Advice on healthy diet and physical activity recommendations

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.

Group Type EXPERIMENTAL

Intervention (training in use of a Smartphone application)

Intervention Type BEHAVIORAL

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.

Control (Advice on healthy diet and physical activity recommendations)

Intervention Type BEHAVIORAL

Advice on healthy diet and physical activity recommendations

Interventions

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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.

Intervention Type BEHAVIORAL

Control (Advice on healthy diet and physical activity recommendations)

Advice on healthy diet and physical activity recommendations

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role collaborator

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jose I Recio-Rodriguez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

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Instituto Biosanitario de Salamanca. Research Unit La Alamedilla

Salamanca, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 36203135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30674284 (View on PubMed)

Other Identifiers

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YB17/00003

Identifier Type: -

Identifier Source: org_study_id

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