Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention (PREDIRCAM 2)

Intensificación y monitorización telemática Personalizada de la modificación Del Estilo de Vida en el Tratamiento de la Obesidad y la prevención Del Riesgo cardiometabólico

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.

Study Overview

• Status: Completed
• Conditions: Obesity Type I and II
• Intervention / Treatment: Other: Standard care; Device: Telemedic assistance with a technological system

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Preclinical Phase:

1. People over 18 years with or without obesity and with ability for technology management

Clinical Phase:

1. People between 18 and 65 years.

2. Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:

   1. Grade I or II without sleep apnea syndrome and ischemic heart disease
   2. Absence of metabolic processes (dyslipidemia) or associated hypertension requiring drug treatment at the time of inclusion in the study.
3. People with ability for technology management

Exclusion Criteria:

Preclinical Phase:

1. Serious illness and / or disabling

Clinical Phase:

1. Diabetes defining according to American Diabetes Association (ADA) criteria.
2. Subjects with moderate to severe active disease at the time of inclusion in the study protocol
3. Impaired glucose metabolism related diseases associated with diabetes mellitus or drugs interfering carbohydrate metabolism.
4. Cardiovascular disease
5. Dyslipidemia or hypertension requiring drug treatment.
6. Alcohol consumption
7. Pregnancy
8. Serious illness and / or disabling

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional assistance; Usual treatment of obesity in terms of monitoring lifestyle habits	Other: Standard care
Experimental: Telemedic assistance; telemedical assistance with a technological system to provide a continuous monitoring of lifestyle habits and individualized treatment of obesity	Device: Telemedic assistance with a technological system; Other Names: PREDIRCAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight loss	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiometabolic risk prevention	We will measure different parameters related to cardiovascular risk, such as adiponectine, tumour necrosis factor, Homeostasis Model Assessment, etc.at the beginning and at the end of the study	1 year

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Spanish Clinical Research Network - SCReN; Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2015
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): January 25, 2018

Study Registration Dates

• First Submitted: August 7, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: IIBSP-MTP-2012-74