Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight

Obesity Clinical Trial

— SUIVIOBESITE  

Official title:

Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374866
• Other study ID #: I13031 SUIVI OBESITE
• Status: Completed
• Phase: N/A
• First received: February 18, 2015
• Last updated: September 2, 2016
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid
• Quality of Life

Intervention

Other:
• closer monitoring

Locations

Country	Name	City	State
France	Centre de suivi de l'obésite Bernard Descottes	St Yrieix la Perche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of weight loss at 12 months		1 year	No
Primary	percentage of change in BMI at 12 months		1 year	No
Secondary	Change of waist at 12 months		1 year	No
Secondary	Changes in body composition		1 year	No
Secondary	Change of quality of life at 12 months		1 year	No
Secondary	Change of medication at 12 months		1 year	No