NCT01919372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 29, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

August 7, 2013

Last Update Submit

March 6, 2018

Conditions

Obesity Type I and II

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    1 year

Secondary Outcomes (1)

  • Cardiometabolic risk prevention

    1 year

Study Arms (2)

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

Telemedic assistance with a technological systemDEVICE
Also known as: PREDIRCAM
Telemedic assistance
Standard careOTHER
Conventional assistance

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preclinical Phase:
  • \. 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:
  • Grade I or II without sleep apnea syndrome and ischemic heart disease
  • People with ability for technology management

You may not qualify if:

  • Preclinical Phase:
  • \. Serious illness and / or disabling
  • Clinical Phase:
  • Diabetes defining according to American Diabetes Association (ADA) criteria.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2013

First Posted

August 9, 2013

Study Start

October 29, 2015

Primary Completion

December 30, 2017

Study Completion

January 25, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

ES(1)