Individualized Telemedical Assistance for Lifestyle Modif... | NCT01919372

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2015Actual

Primary Completion Date

Dec 30, 2017Actual

Completion Date

Jan 25, 2018Actual

First Submitted Date

Aug 7, 2013

First Submission Date that Met QC Criteria

Aug 8, 2013

First Posted Date

Aug 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2018

Last Update Posted Date

Mar 7, 2018Actual

Name	Class
Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid	UNKNOWN
Spanish Clinical Research Network - SCReN	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

183Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional assistance	Active Comparator	Usual treatment of obesity in terms of monitoring lifestyle habits	Other: Standard care
Telemedic assistance	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telemedic assistance with a technological system	Device		Telemedic assistance	PREDIRCAM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Weight loss		1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preclinical Phase:

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

Clinical Phase:

People between 18 and 65 years.
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.
People with ability for technology management

Exclusion Criteria:

Preclinical Phase:

1. Serious illness and / or disabling

Clinical Phase:

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
Dyslipidemia or hypertension requiring drug treatment.
Alcohol consumption
Pregnancy
Serious illness and / or disabling

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation