Department of Epidemiology & Public Health, University College London, Gower Street, London, WC1E 6BT, UK.
BMC Public Health. 2012 Aug 16;12:667. doi: 10.1186/1471-2458-12-667.
Primary care is the first port of call for advice about weight control. There is hence a need for simple, effective interventions that can be delivered without specialist skills. We have developed such an intervention; the 10 Top Tips (10TT). This intervention was effective with respect to weight loss in a volunteer population, but has yet to be tested in primary care. The aim of this trial is therefore to test the effectiveness of the 10TT intervention in primary care, incorporating clinical outcomes and health economic analyses.
METHODS/DESIGN: The trial is a two-arm, individually-randomised, controlled trial in obese (BMI ≥ 30) adults (n = 520) in primary care, comparing weight loss in patients receiving the 10TT intervention with weight loss in a control group of patients receiving usual care. The intervention is based on habit formation theory, using written materials to take people through a set of simple weight control behaviours with strategies to make them habitual; an approach that could make it more successful than others in establishing long-term behaviour change. Patients will be recruited from 14 General Practices across England. Randomisation will be through telephoning a central randomisation service using a computer-generated list of random numbers. Patients are followed up at 3, 6, 12, 18 and 24 months. The primary outcome is weight loss at 3 months, with assessment by a health professional who is blind to group allocation. Other follow-ups will be un-blinded. We will examine whether weight loss is maintained up to 24 months. We will also assess changes in the automaticity of the 10TT target behaviours and improvement in clinical markers for potential co-morbidities. Finally, we will undertake a full economic evaluation to establish cost-effectiveness in the NHS context.
If proven to be effective when delivered through primary care, 10TT could make a highly cost-effective contribution to improvements in population health.
ISRCTN16347068.
初级保健是寻求体重控制建议的第一站。因此，需要一种无需专业技能即可提供的简单有效的干预措施。我们已经开发出这样的干预措施；10 大秘诀（10TT）。该干预措施在志愿者人群中对减肥有效，但尚未在初级保健中进行测试。因此，本试验的目的是在初级保健中测试 10TT 干预措施的有效性，包括临床结果和健康经济学分析。
方法/设计：该试验是一项在初级保健肥胖（BMI≥30）成年人（n=520）中进行的双臂、个体随机对照试验，比较接受 10TT 干预的患者与接受常规护理的对照组患者的体重减轻情况。该干预措施基于习惯形成理论，使用书面材料指导人们完成一套简单的体重控制行为，并制定使其成为习惯的策略；这种方法可能比其他方法更成功地建立长期行为改变。患者将从英格兰的 14 家全科诊所招募。随机化将通过电话拨打中央随机服务，使用计算机生成的随机数列表。患者将在 3、6、12、18 和 24 个月进行随访。主要结果是 3 个月时的体重减轻，由对组分配不知情的健康专业人员进行评估。其他随访将不设盲。我们将检查体重减轻是否在 24 个月内保持。我们还将评估 10TT 目标行为的自动性变化以及潜在合并症的临床标志物的改善。最后，我们将进行全面的经济评估，以确定在 NHS 背景下的成本效益。
如果在初级保健中得到证明有效，10TT 可以为改善人群健康做出非常具有成本效益的贡献。
ISRCTN83267624。
