Evaluation of the Effect of a Lifestyle Intervention Compared to Usual Care on Weight Loss and Changes in Body Composition, Physical Activity Levels and Health-related Quality of Life in the First Year Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- %WL
研究概览
简要总结
The aim of this trial is to evaluate the effect of a post-surgery 12-month lifestyle intervention compared to usual care upon post-surgery weight loss and changes that occur in body composition (relative amounts of body fat, muscle and bone), physical fitness and activity levels, diseases linked to obesity (e.g. diabetes, high blood pressure, high cholesterol level, sleep apnoea) and health-related quality of life (HRQoL) over a 12-month period.
详细描述
People with severe obesity who are scheduled to undergo either primary gastric bypass or primary sleeve gastrectomy will be recruited from the Bariatric Clinics at University College London Hospital (UCLH) and the Whittington Hospital and asked to participate in an observational cohort study. Eligible patients will be given a participant information sheet (PIS) for BARI-LIFESTYLE Observational Study and informed consent will be sought. Recruited patient will attend for 4 research visits, timed to coincide with their clinic visits, at approximately 6 weeks before surgery (Visit 1), 3 month post-surgery (Visit 2), 6 months post-surgery (Visit 3) and 12 months post-surgery (Visit 4). Each research visit will include assessment of body weight, body composition (using bioelectrical impedance analysis), physical fitness and activity levels, obesity-associated co-morbidities, HRQoL and usual care laboratory investigations. Dual energy X-ray absorptiometry (DXA) scanning will be undertaken at Visit 1 and Visit 4, which is not a usual assessment for the post-surgery standard care. All of the research assessments will be done as part of this observational cohort study.
Immediately after surgery has been undertaken, BARI-LIFESTYLE Observational Study participants will be randomised to continue to receive usual care, or usual care plus lifestyle intervention (nutritional and behavioural tele-counselling, self-monitoring and a 12-week supervised tailored exercise programme). However, to avoid contamination between the intervention group and the usual care group, only those randomly allocated to the lifestyle intervention group will be informed of this. They will be given a PIS (BARI-LIFESTYLE Intervention Study) and informed consent will be sought. If the participants decline to take part in the lifestyle programme, they will remain in the control group (observational cohort study).
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
- Single (Outcomes Assessor)
盲法说明
The investigator who will conduct the follow-up assessments at each visit will be blinded to participants' allocation and will not be involved in delivering any of the intervention. The statistician conducting the data analysis will be blind to group allocation.
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
- •Adult aged between 18 to 65 years old.
- •Planned to undergo either primary gastric bypass surgery or primary sleeve gastrectomy surgery and fulfilling NICE eligibility criteria for bariatric surgery.
- •Medically safe to participate in exercise programme.
- •Able to read and write in English.
- •Willing and able to provide written informed consent.
- •Able to comply with study protocol.
- •Able to attend a supervised tailored exercise session at UCLH weekly for 12 weeks.
- •Willing and able to wear a Fitbit wrist-based activity tracker device and an Actigraph device.
排除标准
- •More than 200 kg of body weight (due to limitation of DXA Scanner).
- •Non-ambulatory.
- •Functional limitation.
- •Medical contraindication for exercise.
研究组 & 干预措施
Usual Care
usual care provided by the NHS for patients undergoing bariatric surgery.
Intervention
usual care + BARI-LIFESTYLE intervention
干预措施: Lifestyle intervention (Behavioral)
结局指标
主要结局
%WL
时间窗: 52 weeks
The primary objective of this trial is to compare the 1-year post-surgery percentage weight loss (%WL) in people receiving usual care and people receiving a post-operative lifestyle intervention programme.
次要结局
- body fat(52 weeks)
- bone mineral density(52 weeks)
- skeletal muscle mass(52 weeks)
- physical activity (PA) levels(12, 26 and 52 weeks)
- 150 minutes of activity(12, 26 and 52 weeks)
- sedentary time(12, 26 and 52 weeks)
- 6MWT(12, 26 and 52 weeks)
- STS(12, 26 and 52 weeks)
- Handgrip test(12, 26 and 52 weeks)
- 36-Item Short-Form Health Survey Instrument (SF-36)(12, 26 and 52 weeks)
- Impact of Weight on Quality of Life-Lite (IWQOL-Lite)(12, 26 and 52 weeks)
- Beck Depression Inventory (BDI)(12, 26 and 52 weeks)
- Medical history(12, 26 and 52 weeks)