Monitoring Obese Patients: Impact on the Frequency of Monitoring Weight, Quality of Life, Dietary Behavior, Physical Ability and Comorbidities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- percentage of change in BMI at 12 months
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- 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.
结局指标
主要结局
percentage of change in BMI at 12 months
时间窗: 1 year
percentage of weight loss at 12 months
时间窗: 1 year
次要结局
- Changes in body composition(1 year)
- Change of waist at 12 months(1 year)
- Change of quality of life at 12 months(1 year)
- Change of medication at 12 months(1 year)