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

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).

Study Overview

• Status: Completed
• Conditions: Quality of Life; Obesity; Morbid Obesity
• Intervention / Treatment: Other: closer monitoring

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 Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • St Yrieix la Perche, France, 87500
    • Centre de suivi de l'obésite Bernard Descottes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional monitoring; 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.
Experimental: Closer monitoring; 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.	Other: closer monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of weight loss at 12 months	1 year
percentage of change in BMI at 12 months	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of waist at 12 months	1 year
Changes in body composition	1 year
Change of quality of life at 12 months	1 year
Change of medication at 12 months	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Cécile de Rouvray, Md, Centre de l'Obesite Bernard Descottes

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 5, 2016
• Last Update Submitted That Met QC Criteria: September 2, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; Morbid Obesity; Therapeutic education
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: I13031 SUIVI OBESITE