Greaves Colin, Gillison Fiona, Stathi Afroditi, Bennett Paul, Reddy Prasuna, Dunbar James, Perry Rachel, Messom Daniel, Chandler Roger, Francis Margaret, Davis Mark, Green Colin, Evans Philip, Taylor Gordon
University of Exeter Medical School, St Luke's Campus, Magdalen Road, Exeter, EX1 2LU, UK.
University of Bath, Claverton Down, Bath, BA2 7AY, UK.
Int J Behav Nutr Phys Act. 2015 Jan 16;12:1. doi: 10.1186/s12966-014-0159-z.
In the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence-informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight.
Patients aged 40-74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months.
108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% provided data at both 4 and 12 months. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co-interventions and co-morbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: -4.8 to -0.3, p = 0.025). No significant differences were found in physical activity.
The Waste the Waist intervention is deliverable in UK primary care, has acceptable recruitment and retention rates and produces promising preliminary weight loss results. Subject to refinement of the physical activity component, it is now ready for evaluation in a full-scale trial.
Current Controlled Trials ISRCTN10707899 .
在英国，一项全国风险评估计划（国民健康服务健康检查）识别出了数千名心血管疾病高风险人群。“甩掉腰间赘肉”是一项基于证据、理论驱动（改良的健康行动过程方法）的群体干预措施，旨在促进心血管疾病高风险人群的健康饮食和体育锻炼。这项试点随机对照试验旨在评估在英国初级医疗保健中实施“甩掉腰间赘肉”干预措施以及开展全面随机对照试验的可行性。我们还对体重变化进行了探索性分析。
从风险评估数据或实践数据库搜索中识别出年龄在40 - 74岁、体重指数为28或更高且心血管疾病风险高的患者。参与者通过在线计算机随机算法进行随机分组，分别接受常规护理以及关于心血管疾病风险和生活方式的标准化信息（对照组），或参加九节“甩掉腰间赘肉”课程（干预组）。在随机分组之前，组分配情况是保密的。此后，统计人员对组分配情况不知情，但参与者和数据收集人员知晓。在0、4和12个月时测量体重、体育活动（加速度计测量）和心血管疾病风险标志物（血液检测）。
从6个医疗机构招募了108名参与者（占所接触人群的22%）（55名干预组，53名对照组），89%的参与者在4个月和12个月时都提供了数据。参与者的平均年龄为65岁，70%为男性。干预组参与者参加了72%的小组课程。根据末次观察值结转法，干预组在12个月时体重减轻并不显著多于对照组，不过在考虑可能影响体重的联合干预措施和合并症时，差异具有统计学意义（平均差值2.6千克，95%置信区间：-4.8至-0.3，p = 0.025）。在体育活动方面未发现显著差异。
“甩掉腰间赘肉”干预措施在英国初级医疗保健中是可行的，招募和留存率可接受，并且产生了有前景的初步体重减轻结果。在对体育活动部分进行完善后，现在已准备好在全面试验中进行评估。
当前受控试验ISRCTN10707899 。
