A Comprehensive Remote Intervention Program for Weight Regain After Sleeve Gastrectomy: An Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The effect of a comprehensive remote multidisciplinary intervention program focused on weight regain after sleeve gastrectomy on weight change, compared to a control group.
研究概览
简要总结
The study is designed to assess the effect of a 3-month remote comprehensive intervention program by a multidisciplinary team combined with mobile supportive text messages aimed to raise the level of happiness and subjective wellbeing, on weight outcomes and physical and behavioral parameters among bariatric surgery patients after sleeve gastrectomy who had a weight regain of ≥10% from nadir, compared to a control group which will receive standard care of a single meeting with the study's registered dietitian at the clinic and then be advised to continue follow up.
详细描述
One hundred patients will be recruited to the study and randomized to intervention or control group. The comprehensive 3-month remote intervention program by the multidisciplinary study team includes 6-weeks of online meetings with the study registered dietitian, sleep and physical activity consultants, followed by another 6-weeks of online meetings with the study RD, overall 12 weeks containing a total of 12 remote consultations (6 dietitian, 3 physical activity consultant, 3 sleep consultant). In addition, the intervention group will receive weekly text messages to their mobile phone, meant to enhance happiness and subjective wellbeing.
The control group will receive standard care of a single meeting with the study's registered dietitian at the clinic including nutrition and behavioral recommendations and then advised to continue follow up, engage in physical activity and general lifestyle recommendations.
Both groups will undergo comprehensive tests at baseline and at the end of intervention after 3 months. Patients from both groups who will arrive to the follow-up appointment after 3 months will receive a participation reward which will include a gift card on the sum of 154 NIS for purchasing a multivitamin package for bariatric patients.
Finally, 3 and 6 months after intervention completion, self-reported data will be collected via phone calls including weight, physical activity (type, times per week and duration per time), professional follow up and adherence to BS recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Age at the time of BS ≥18 years
- •Patients who underwent primary SG at least 2 years ago and regained at least 10% weight from nadir.
- •Read and speak Hebrew.
排除标准
- •Patients who underwent more than one BS in their past.
- •Use of weight loss drug therapy currently or 1-month prior to trial entry.
- •Currently attending a weight loss program and lost more than 5% of weight at the last month.
- •Current pregnancy and women who gave birth in the last 6 months.
- •Medical contraindications such as active cancer, organ transplant or unbalanced psychiatric disorders.
结局指标
主要结局
The effect of a comprehensive remote multidisciplinary intervention program focused on weight regain after sleeve gastrectomy on weight change, compared to a control group.
时间窗: Changes from baseline at 3 months
Weight change in kilograms will be measured before and at the end of the 3-month intervention, for both intervention and control group.
次要结局
- The effect of the intervention on behavioral recommendations.(Changes from baseline at 3, 6, and 9 months)
- The effect of the intervention on grazing.(Changes from baseline at 3 months)
- The effect of the intervention on food tolerance.(Changes from baseline at 3 months)
- The effect of the intervention on subjective binge eating.(Changes from baseline at 3 months)
- The effect of the intervention on dietary intake by food diaries.(Changes from baseline at 3 months)
- The effect of the intervention on dietary intake by 24-hour recall.(Changes from baseline at 3 months)
- The effect of the intervention on dietary intake by food frequency questionnaire (FFQ).(Changes from baseline at 3 months)
- The effect of the intervention on food environment's impact on eating behaviors.(Changes from baseline at 3 months)
- The effect of the intervention on physical activity habits.(Changes from baseline at 3, 6, and 9 months)
- The effect of the intervention on functionality regarding upper extremity strength.(Changes from baseline at 3, 6, and 9 months)
- The effect of the intervention on functionality regarding lower extremity strength .(Changes from baseline at 3, 6, and 9 months)
- The effect of the intervention on sleeping habits.(Changes from baseline at 3 months)
- The effect of the intervention on sleeping hours.(Changes from baseline at 3 months)
- The effect of the intervention on happiness and subjective wellbeing(Changes from baseline at 3, 6, and 9 months)
- The effect of the intervention on weight 3 and 6 months after the end of the intervention.(Changes from baseline at 3, 6, and 9 months)
- The effect of the intervention on attendance to follow up meetings 3 and 6 months after the end of the intervention.(Changes from baseline at 3, 6, and 9 months)
- The effect of the intervention on supplementation usage 3 and 6 months after the end of the intervention.(Changes from baseline at 3, 6, and 9 months)
研究者
Shiri Sherf Dagan
Dr Shiri Sherf-Dagan (RD, PhD) Dietitian and Epidemiologist, Principal Investigator
Assuta Medical Center