Smartphone Applications to Improve Lifestyles in Olders Over 65 Years

Study Overview
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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.

Official Title
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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

Conditions
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Telemedicine

Intervention / Treatment
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* Behavioral: Intervention (training in use of a Smartphone application)
* Behavioral: Control (Advice on healthy diet and physical activity recommendations)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Advice on healthy diet and physical activity recommendations | Behavioral: Control (Advice on healthy diet and physical activity recommendations)<br>* Advice on healthy diet and physical activity recommendations<br>|
| Experimental: Intervention<br>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: Intervention (training in use of a Smartphone application)<br>* 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.<br>Behavioral: Control (Advice on healthy diet and physical activity recommendations)<br>* Advice on healthy diet and physical activity recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, Lifestyles, Elderly, Body composition, Cognitive performance, Quality of life