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Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight (SUIVIOBESITE)

Primary Purpose

Obesity, Morbid Obesity, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
closer monitoring
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Obesity, Morbid Obesity, Therapeutic education

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • - 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

Exclusion Criteria:

  • - 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.

Sites / Locations

  • Centre de suivi de l'obésite Bernard Descottes

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional monitoring

Closer monitoring

Arm Description

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 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.

Outcomes

Primary Outcome Measures

percentage of weight loss at 12 months
percentage of change in BMI at 12 months

Secondary Outcome Measures

Change of waist at 12 months
Changes in body composition
Change of quality of life at 12 months
Change of medication at 12 months

Full Information

First Posted
February 18, 2015
Last Updated
September 2, 2016
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT02374866
Brief Title
Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight
Acronym
SUIVIOBESITE
Official Title
Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid Obesity, Quality of Life
Keywords
Obesity, Morbid Obesity, Therapeutic education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional monitoring
Arm Type
No Intervention
Arm Description
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.
Arm Title
Closer monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
closer monitoring
Primary Outcome Measure Information:
Title
percentage of weight loss at 12 months
Time Frame
1 year
Title
percentage of change in BMI at 12 months
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change of waist at 12 months
Time Frame
1 year
Title
Changes in body composition
Time Frame
1 year
Title
Change of quality of life at 12 months
Time Frame
1 year
Title
Change of medication at 12 months
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - 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 Exclusion Criteria: - 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile de Rouvray, Md
Organizational Affiliation
Centre de l'obésité Bernard Descottes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de suivi de l'obésite Bernard Descottes
City
St Yrieix la Perche
ZIP/Postal Code
87500
Country
France

12. IPD Sharing Statement

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Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight

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