Fitbit / Healthy Weight Management Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Percentage of excess weight loss
研究概览
简要总结
Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve gastrectomy surgery, the investigators would like to determine if the Fitbit is associated with health outcomes in this population.
Primary Outcome
• Percentage of excess weight loss - Does the use of a Fitbit positively affect the percentage of excess body weight loss in vertical sleeve gastrectomy patients?
Secondary Outcomes
- Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive lifestyle and exercise pattern changes in post-operative VSG patients?
- Resolution of comorbidity - Does the use of a Fitbit positively affect patient health via reduction of co-morbid conditions associated with morbid obesity following VSG surgery?
详细描述
Study Aims Specifically with our Healthy Weight Management patients that are pursuing sleeve gastrectomy surgery, the investigators would like to determine if the Fitbit is associated with health outcomes in this population.
Primary Outcome
• Percentage of excess weight loss - Does the use of a Fitbit positively affect the percentage of excess body weight loss in vertical sleeve gastrectomy patients?
Secondary Outcomes
- Lifestyle changes and Exercise patterns - Does the use of a Fitbit foster positive lifestyle and exercise pattern changes in post-operative VSG patients?
- Resolution of comorbidity - Does the use of a Fitbit positively affect patient health via reduction of co-morbid conditions associated with morbid obesity following VSG surgery?
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Naive bariatric surgery procedure patients - approved for surgery
- •Laparoscopic VSG patients
- •Completion of all pre-surgical requirements
- •Subject must have a My LG Health account activated
- •Subject must have a PC and/or Bluetooth enabled device at home
排除标准
- •Band procedures
- •Revisions
- •All other bariatric procedures
- •Non-English speaking patient (justification - My LG Health information and support is only available in English)
- •Already own and use a Fitbit type device
- •Cognitive impairments or lack of support that would limit the abilities to comply with study procedures or use of a diary/Fitbit
研究组 & 干预措施
Intervention
At the 2 week post-surgical visit, subjects will receive and be trained in the use of the Fitbit and data interface and meet with the exercise physiologist or research coordinator to initiate MyLGHealth, lifestyle/activity data collection.
Subsequent data collection time-points correspond with follow-up post-surgical appointments either at each visit or the 2 week, 1 month, 4 month, 8 month or 12 month visit.
干预措施: Fitbit (Behavioral)
Control
At the 2 week post-surgical visit, all subjects will then meet with the exercise physiologist or research coordinator to initiate MyLGHealth, lifestyle/activity data collection.
Subsequent data collection time-points correspond with follow-up post-surgical appointments either at each visit or the 2 week, 1 month, 4 month, 8 month or 12 month visit.
The control group will receive a current version of the Fitbit device at the end of their completion of the 12 month visit.
Historical Control
The investigators will extract historical control data from the electronic health record using electronic queries and manual data extraction. Historical controls will have surgery and 12-month follow-up completed prior to the start of the RCT.
结局指标
主要结局
Percentage of excess weight loss
时间窗: 1 year
Does the use of a Fitbit positively affect the percentage of excess body weight loss in VSG patients? Subjects enrolled in the study will have ideal body weight (IBW) calculated upon entry into the bariatric program and entered into the electronic health record. IBW calculations are based on the Met Life IBW charts. EWL at the end of one year will be calculated as follows: EWL% = (ABW - CW)/EBW \*100 EWL%: Percentage of excess weight loss CW: Current weight (to be collected at regular intervals during the study, but for purposes of this objective, the measure collected at the 1 year visit) ABW: Actual body weight at baseline - date approved for surgery and entering pre-surgical period EBW: Excess body weight = ABW - IBW IBW: Ideal body weight based on Met Life IBW charts
次要结局
- Changes and physical activity patterns(1 year)
- Resolution of comorbidity(1 year)