Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight

NCT02374866 | Completed

• 1 other identifier: I13031 SUIVI OBESITE
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity; Morbid Obesity; Quality of Life

Keywords

Obesity; Morbid Obesity; Therapeutic education

Outcome Measures

Primary Outcomes (2)

• percentage of weight loss at 12 months

  1 year

• percentage of change in BMI at 12 months

  1 year

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Other: closer monitoring

Interventions

closer monitoring OTHER

Closer monitoring

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Centre de suivi de l'obésite Bernard Descottes

Saint-Yrieix-la-Perche, 87500, France

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cécile de Rouvray, Md

  Centre de l'Obesite Bernard Descottes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 2, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

FR (1)