Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and … (NCT01919372) | Clinical Trial Compass
CompletedNot Applicable
Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention
Spain183 participantsStarted 2015-10-29
Plain-language summary
This project is based on the contribution that could offer a technological system for a continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic complications in high risk population.
The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in high cardiometabolic risk individuals of a telemedical platform integrating applications for monitoring and providing recommendations to improve lifestyle habits (diet and physical activity) in a healthier way.
The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12 month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic assistance with a technological system and its ability to modify lifestyle habits, reduce weight and cardiovascular risk associated parameters.
Previously to the clinical implementation, a pilot study for testing the telemedical system will be made. Efficacy and security variables will be evaluated along the study.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. People between 18 and 65 years.
✓. Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:
✓. Grade I or II without sleep apnea syndrome and ischemic heart disease
✓. Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study.
✓. People with ability for technology management
Exclusion criteria
✕. Diabetes defining according to American Diabetes Association (ADA) criteria.
✕. Subjects with moderate to severe active disease at the time of inclusion in the study protocol
✕. Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism.
✕. Cardiovascular disease
✕
What they're measuring
1
Weight loss
Timeframe: 1 year
Trial details
NCT IDNCT01919372
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau