Effectiveness to Weight Loss in Sedentary and Overweight People Using a Smartphone Application. (EVIDENT3)

Instituto de Investigación Biomédica de Salamanca

Status: Completed

Conditions: Healthy

Treatments: Other: Control: Lifestyle counseling; Other: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT03175614

PI16/00101

GRS 1277/B/16 (Other Grant/Funding Number)

PI16/00170 (Other Grant/Funding Number)

Details and patient eligibility

About

This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the effects of the addition of an ICT tool developed for the Smartphone application and a Smartband in support of behavioral and educational recommendations to reduce weight.

Full description

• Objetive: To develop and validate an application for the use in Smartphone in which the management of a SmartBand is included and evaluate the effect of adding this tool of information and communication technology (ICT), to a standardized intervention reduce weight, reduce sedestation time, increase physical activity and decrease total caloric intake in obese and sedentary subjects.
• Design and setting: A clinical of two parallel group, multicenter, randomized, aimed at assessing the effects of adding an ICT tool (intervention) to support behavioral and educational recommendations (control) in physical activity and weigh loss. Population: 700 obese and sedentary subjects will be included, 20 to 65 aged, selected by random sampling in 5 centers.
• Measurements and intervention: physical and sedeentary acivity will be assessed with an accelometer and IPAQ and Marshall Questionnaires, the nutrition by a food frequency and adherence to the Mediterranean diet survey and weight loss with body mass index and waist circumference. Vascular function with a wrist-worn tonometer (blood pressure, augmentation index and pulse rate) will be evaluated and also the Cardio Ankle Vascular Index and carotid intima media thickness. The advice on nutrition (plate method) and exercise will be common to both groups. The intervention group will be added a training for 3 months in use of ICT tool described, designed to foment a healthy and low-calorie diet and increased physical acivity and decreased sedentary.

Enrollment: 650 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obese subjects (IMC ≥ 27.5 to <40), classified as sedentary according to the short physical activity questionnaire validated in the EVIDENT II study.

Exclusion criteria

• Older than 65 years are excluded, due to difficulties in the use of ICTs.
• Advanced respiratory, renal or liver disease.
• Several mental illness
• Coronary or cerebrovascular atherosclerotic disease, grade II or higher NYHA heart failure.
• Moderate or severe COPD
• Muscular-skeletal pathology that inhibit mobility
• Subjects who can not exercise or follow a hypocaloric diet.
• Oncologic disease in treatment diagnosed in the last 5 years.
• Terminal situation
• Pregnancy
• Bariatric surgery
• Those with any other circumstance that the investigators consider could interfere with the study procedures

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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650 participants in 2 patient groups

Control: Lifestyle counseling

Active Comparator group

Description:

Counseling on physical activity and nutrition.

Treatment:

Other: Control: Lifestyle counseling

Intervention group

Experimental group

Description:

Add for three months a Smartphone with an app (EVIDENT III) and a Smartband to lose weight and improve physical activity.

Treatment:

Other: Intervention group

Other: Control: Lifestyle counseling