Clinical trial NCT02374866: Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight
Official title: Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Morbid Obesity
Quality of Life
Keywords: Obesity
Morbid Obesity
Therapeutic education
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: percentage of weight loss at 12 months
timeFrame: 1 year
measure: percentage of change in BMI at 12 months
timeFrame: 1 year
Secondary outcomes:
measure: Change of waist at 12 months
timeFrame: 1 year
measure: Changes in body composition
timeFrame: 1 year
measure: Change of quality of life at 12 months
timeFrame: 1 year
measure: Change of medication at 12 months
timeFrame: 1 year
Other outcomes:
Locations:
city: St Yrieix la Perche
country: France
facility: Centre de suivi de l'obésite Bernard Descottes
Study officials:
affiliation: Centre de l'Obesite Bernard Descottes
name: Cécile de Rouvray, Md
role: PRINCIPAL_INVESTIGATOR
References: