Smartphone Applications to Improve Lifestyles in Olders Over 65 Years

Not Applicable

Completed

• Conditions: Telemedicine
• Interventions: Behavioral: Control (Advice on healthy diet and physical activity recommendations); Behavioral: Intervention (training in use of a Smartphone application)

• Registration Number: NCT03574480
• Lead Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

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.

Study Timeline

• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-02
• Study Start: 2018-09-05
• Status Verified: 2020-02
• Primary Completion: 2020-05-31
• Study Completion: 2020-09-30
• Last Update Submitted: 2022-11-13
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control (Advice on healthy diet and physical activity recommendations)	Advice on healthy diet and physical activity recommendations
Intervention	Intervention (training in use of a Smartphone application)	* 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.
Intervention	Control (Advice on healthy diet and physical activity recommendations)	* 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.

Primary Outcome Measures

Name	Time	Method
Physical activity	3 months	Measurement by accelerometer (steps/day)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto Biosanitario de Salamanca. Research Unit La Alamedilla; 🇪🇸 Salamanca, Spain