Impact of the Use of Health-connected Devices on Recovery of Physical Activity in Obese Patients After Bariatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change from baseline mean number of steps per day at 6th month
研究概览
简要总结
The goal of clinical trial is to evaluate the impact of use of health-connected devices and of an Internet-based Intensive follow-up on physical activity recovery during the 6-month period after bariatric surgery in obese patients.
详细描述
90 patients with morbid obesity, having recently benefited from an act of bariatric surgery will be recruited for clinical trial if they meet the inclusion and no inclusion criteria. This is a single-center, open, controlled, randomized, 2 parallel-groups:
- "Mobility Coaching" group
- "Diet Coaching" group
The "Diet Coaching" group will be the "control group" of "Mobility Coaching" group and vice versa.
Patients in both groups will be equipped with a connected-scale and a wristwatch equipped with a pedometer connected. The online tools available to patients will be used to motivate patients to progress and alert the coaches and the medical team in case of difficulties to achieve the objectives.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primo-surgery bariatric surgery a week before their inclusion
- •Absence of surgical side events related to the surgical procedure
- •Adult female or male
- •Weight ≤ 150 kg
- •Knowing read and write French routinely,
- •Possessing an internet connection at home,
- •Possessing and knowing how to use a computer or tablet,
- •Owning a smartphone,
- •Affiliated with a social security scheme
- •Not Trust
- •Having signed the informed consent letter
- •Non-inclusion criteria • Patient with major disabilities causing a definitive loss of mobility
排除标准
- 未提供
研究组 & 干预措施
Mobility Coaching
45 patients undergoing bariatric surgery received a monthly "mobility" coaching session of 20 to 30 min by phone during 6 months.
干预措施: Mobility coaching (Behavioral)
Diet Coaching
45 patients undergoing bariatric surgery received a monthly "diet" coaching session of 20 to 30 min by phone during 6 months.
干预措施: Diet coaching (Behavioral)
结局指标
主要结局
Change from baseline mean number of steps per day at 6th month
时间窗: Period from Day 164 to Day 179
The primary endpoint is the difference between mean number of steps recorded by the pedometer during the last 15 days of the 6th month (Period Day 164 to Day 179) and the mean number of steps per day recorded in the last 15 days of the first month (Period Day 15 to Day 30). .
次要结局
- % of patients having nutritional deficiency in vitamins and / or minerals(At 6th month)
- Change from baseline Quality of life at 6th month(At the 6th month)
- Change from baseline Quality of life at 3rd month(At the 3rd month)
- Change from baseline mean number of steps per day at 3rd month(Period from Day 75 to Day 90)
- Change from baseline weight at 6th month(At 6th month)
- Change from baseline weight at 3rd month(At 3rd month)
- Change from baseline mean daily energy expenditure at 3rd month(At 3rd month)
- Change from baseline mean daily energy expenditure at 6th month(At 6th month)