Obesity Type I and IIPREDIRCAM 2NCT01919372
Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention
A study testing Telemedic assistance with a technological system in people with Obesity Type I and II, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity Type I and II
- What is being tested?
- Telemedic assistance with a technological system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteSpain
- Study dates
- 29 Oct 2015to 25 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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.
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- Cardiovascular disease
- Dyslipidemia or hypertension requiring drug treatment.
- Alcohol consumption
- Pregnancy
- Serious illness and / or disabling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Obesity Type I and II
- Being tested
- Telemedic assistance with a technological system, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedic assistance with a technological systemDevice
Also called PREDIRCAM
Standard careOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional assistance | Active comparator | Usual treatment of obesity in terms of monitoring lifestyle habits Receives: 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 Receives: Device: Telemedic assistance with a technological system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study start29 Oct 2015
- Primary completion30 Dec 2017
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Type I and IIStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid, Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919372
- Sponsor's protocol ID
- IIBSP-MTP-2012-74
- Acronym
- PREDIRCAM 2
- Status last verified
- Mar 2018
- First submitted
- 7 Aug 2013
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensificación y monitorización telemática Personalizada de la modificación Del Estilo de Vida en el Tratamiento de la Obesidad y la prevención Del Riesgo cardiometabólico
- ClinicalTrials.gov ID
- NCT01919372
- Acronym / sponsor ID
- PREDIRCAM 2 / IIBSP-MTP-2012-74
- Conditions
- Obesity Type I and II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Grupo de Bioingenieria y Telemedicina -ETSI Telecomunicacion. Universidad Politecnica de Madrid, Spanish Clinical Research Network - SCReN
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional assistance | Active comparator | Other: Standard careUsual treatment of obesity in terms of monitoring lifestyle habits |
| Telemedic assistance | Experimental | Device: Telemedic assistance with a technological systemtelemedical assistance with a technological system to provide a continuous monitoring of lifestyle habits and individualized treatment of obesity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. People over 18 years with or without obesity and with ability for technology management
- People between 18 and 65 years.
- Obesity defined as a body mass index (BMI) greater than or equal to 30 kg/m2:
- People with ability for technology management
Key exclusion criteria (11 listed)
- 1. Serious illness and / or disabling
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedic assistance with a technological systemAlso: PREDIRCAM | Device | Telemedic assistance |
| Standard care | Other | Conventional assistance |
Primary outcome
Weight loss
Time frame: 1 year
1 secondary outcome
Cardiometabolic risk prevention
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedic assistance with a technological system in people with Obesity Type I and II, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2018.