ObesitySUIVIOBESITENCT02374866
Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight
A study testing closer monitoring in people with Obesity and Morbid Obesity, run by University Hospital, Limoges at 1 site in France.
Trial summary
The literature data show that long-term monitoring has an effect on weight loss, comorbidity and on improving the quality of life. However, there are still no studies on monitoring obese patients after taking initial multidisciplinary approach. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Morbid Obesity, Quality of Life
- What is being tested?
- closer monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Jul 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥ 18 - ≤ 75 years
- Obesity with a BMI ≥ 35 or ≥ 30 if associated with at least one comorbidity whose support was commenced or continued during the initial hospitalization.
- Patients hospitalized for a period of at least 3 weeks in the Bernard Descottes center and were supported on dietary, psychological, psychomotor and physical education in a therapeutic approach.
- Patients who have signed consent form.
- Patients who never underwent bariatric surgery and bariatric surgery have not seen in the year following their hospitalization in Bernard Descottes Center.
- Patient accepting the constraints of the protocol in case of close monitoring.
- Patients able to travel with their own vehicle to Bernard Descottes Center.
- Affiliate or beneficiary of a social security scheme
Who cannot join
- - Patients who have hospitalized in Bernard Descottes Center.
- Failure to follow the protocol because of insufficient command of French or concomitant illness.
- Pregnant or breastfeeding.
- Patients under guardianship or under judicial protection.
- Participation to another trial which can impact on patient's experimental disease during all the study, and patients who are in an exclusion period of another trial.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de suivi de l'obésite Bernard Descottes
Saint-Yrieix-la-Perche, 87500
About this study
Official title: Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities
The literature data show that long-term monitoring has an effect on weight loss, comorbidity and on improving the quality of life. However, there are still no studies on monitoring obese patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011 advocated "continuous monitoring needed to prevent weight regain, monitor the consequences of overweight and treat comorbidities. This requires a long-term support. "The frequency of follow-up consultations is not specified and "must be adapted to achieve a weight loss target and maintain." Having no specific recommendations on the frequency of monitoring, the investigators chose to experiment closer monitoring than our current monitoring to assess what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding behavior, changes in physical abilities, evolution of comorbidities associated with obesity. The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).
Read the detailed description
2 groups of randomized patients will be followed:
- The control group will follow the current center: every four months for a year, combined with monitoring by email or regular mail during the year.
- The experimental group will be a follow-up every two months for one year HDJ more of the same followed by email or postal mail.
Follow by email or mail is identical to the control group, as well as HDJ 12 months.
- Conditions
- Obesity, Morbid Obesity, Quality of Life
- Being tested
- closer monitoring
- Keywords
- Obesity, Morbid Obesity, Therapeutic education
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closer monitoringOther
| Study group | Role | What they receive |
|---|---|---|
| Conventional monitoring | No intervention | The control group will follow the current center: every four months for a year, combined with monitoring by email or regular mail during the year. |
| Closer monitoring | Experimental | The experimental group will follow a closer monitoring than the control group : every two months for one year in,stead of every 4 months for a year.
Follow by email or mail is identical to the control group. Receives: Other: closer monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of weight loss at 12 months
Measured: 1 year
percentage of change in BMI at 12 months
Measured: 1 year
Secondary outcomes (4)
Change of waist at 12 months
Measured: 1 year
Changes in body composition
Measured: 1 year
Change of quality of life at 12 months
Measured: 1 year
Change of medication at 12 months
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 posted2 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile de Rouvray, Md, Principal investigator, Centre de l'Obesite Bernard Descottes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374866
- Sponsor's protocol ID
- I13031 SUIVI OBESITE
- Acronym
- SUIVIOBESITE
- Status last verified
- Sep 2016
- First submitted
- 18 Feb 2015
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities
- ClinicalTrials.gov ID
- NCT02374866
- Acronym / sponsor ID
- SUIVIOBESITE / I13031 SUIVI OBESITE
- Conditions
- Obesity, Morbid Obesity, Quality of Life
- Keywords
- Obesity, Morbid Obesity, Therapeutic education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Mar 2015 (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.
The literature data show that long-term monitoring has an effect on weight loss, comorbidity and on improving the quality of life. However, there are still no studies on monitoring obese patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011 advocated "continuous monitoring needed to prevent weight regain, monitor the consequences of overweight and treat comorbidities. This requires a long-term support. "The frequency of follow-up consultations is not specified and "must be adapted to achieve a weight loss target and maintain." Having no specific recommendations on the frequency of monitoring, the investigators chose to experiment closer monitoring than our current monitoring to assess what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding behavior, changes in physical abilities, evolution of comorbidities associated with obesity. The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).
Detailed description
2 groups of randomized patients will be followed:
- The control group will follow the current center: every four months for a year, combined with monitoring by email or regular mail during the year.
- The experimental group will be a follow-up every two months for one year HDJ more of the same followed by email or postal mail.
Follow by email or mail is identical to the control group, as well as HDJ 12 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional monitoring | No intervention | –The control group will follow the current center: every four months for a year, combined with monitoring by email or regular mail during the year. |
| Closer monitoring | Experimental | Other: closer monitoringThe experimental group will follow a closer monitoring than the control group : every two months for one year in,stead of every 4 months for a year. Follow by email or mail is identical to the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - Age ≥ 18 - ≤ 75 years
- Obesity with a BMI ≥ 35 or ≥ 30 if associated with at least one comorbidity whose support was commenced or continued during the initial hospitalization.
- Patients hospitalized for a period of at least 3 weeks in the Bernard Descottes center and were supported on dietary, psychological, psychomotor and physical education in a therapeutic approach.
- Patients who have signed consent form.
- Patients who never underwent bariatric surgery and bariatric surgery have not seen in the year following their hospitalization in Bernard Descottes Center.
Key exclusion criteria (5 listed)
- - Patients who have hospitalized in Bernard Descottes Center.
- Failure to follow the protocol because of insufficient command of French or concomitant illness.
- Pregnant or breastfeeding.
- Patients under guardianship or under judicial protection.
- Participation to another trial which can impact on patient's experimental disease during all the study, and patients who are in an exclusion period of another trial.
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 |
|---|---|---|
| closer monitoring | Other | Closer monitoring |
Primary outcome
percentage of weight loss at 12 months
Time frame: 1 year
percentage of change in BMI at 12 months
Time frame: 1 year
4 secondary outcomes
Change of waist at 12 months
Time frame: 1 year
Changes in body composition
Time frame: 1 year
Change of quality of life at 12 months
Time frame: 1 year
Change of medication at 12 months
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 5 Sep 2016.
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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.
Cécile de Rouvray, Md principal investigator
Centre de l'Obesite Bernard Descottes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closer monitoring in people with Obesity and Morbid Obesity, run by University Hospital, Limoges at 1 site in France.
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 5 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 5 Sep 2016. 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 France. 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?
percentage of weight loss at 12 months (time frame: 1 year). The study lists 2 primary outcomes in all. 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 5 Sep 2016.