Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: protocol of a randomised controlled trial.

Effect of communicating genetic and phenotypic risk for type 2 diabetes in combination with lifestyle advice on objectively measured physical activity: protocol of a randomised controlled trial.
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DOI:
10.1186/1471-2458-12-444
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发表时间:
2012-06-18
期刊:
影响因子:
4.5
通讯作者:
Griffin SJ
Griffin SJ
中科院分区:
医学2区
文献类型:
--
作者:
Godino JG;van Sluijs EM;Marteau TM;Sutton S;Sharp SJ;Griffin SJ

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2型糖尿病(T2D)与发病率和过早死亡的风险增加有关。在高危人群中,通过健康的行为改变,发病率可以减半。关于T2D遗传和表型风险的信息现在已经广泛可用。这些信息是否会促使行为改变尚不清楚。我们的目的是评估T2D的遗传和表型风险对降低风险的健康行为、焦虑和其他基于认知和情绪理论的行为改变的影响。在一个平行组,开放随机对照试验中,将从正在进行的以人口为基础的观察性芬兰研究(英国剑桥郡)中招募大约580名1950年至1975年出生的成年人。符合条件的参与者将接受临床、人体测量和社会心理测量,对23种与T2D相关的单核苷酸多态性进行基因分型,并连续6天6夜佩戴联合心率监测仪和加速计(Actiheart®)来评估身体活动。参与者被随机分为两组,一组单独接受标准生活方式建议(对照组),另一组结合T2D的遗传或表型风险评估(干预组)。主要结果是客观测量的身体活动。次要结果包括自我报告的饮食、自我报告的体重、身体活动和健康饮食的意愿、焦虑、与糖尿病相关的担忧、自我评估的健康状况以及其他认知和情感结果。干预后8周进行随访。根据基线调整后的随访值将在随机分组之间进行比较。这项研究将为提供有关T2D遗传和表型风险信息的影响提供急需的证据。重要的是,它将是第一个使用随机对照试验设计、基于人群的样本和客观测量的行为结果来检查遗传风险信息影响的研究之一。这项试验的结果,以及最近对类似研究的证据综合,应该为有关遗传风险信息的可得性和使用的政策提供信息。当前对照试验ISRCTN09650496
Type 2 diabetes (T2D) is associated with increased risk of morbidity and premature mortality. Among those at high risk, incidence can be halved through healthy changes in behaviour. Information about genetic and phenotypic risk of T2D is now widely available. Whether such information motivates behaviour change is unknown. We aim to assess the effects of communicating genetic and phenotypic risk of T2D on risk-reducing health behaviours, anxiety, and other cognitive and emotional theory-based antecedents of behaviour change. In a parallel group, open randomised controlled trial, approximately 580 adults born between 1950 and 1975 will be recruited from the on-going population-based, observational Fenland Study (Cambridgeshire, UK). Eligible participants will have undergone clinical, anthropometric, and psychosocial measurements, been genotyped for 23 single-nucleotide polymorphisms associated with T2D, and worn a combined heart rate monitor and accelerometer (Actiheart®) continuously for six days and nights to assess physical activity. Participants are randomised to receive either standard lifestyle advice alone (control group), or in combination with a genetic or a phenotypic risk estimate for T2D (intervention groups). The primary outcome is objectively measured physical activity. Secondary outcomes include self-reported diet, self-reported weight, intention to be physically active and to engage in a healthy diet, anxiety, diabetes-related worry, self-rated health, and other cognitive and emotional outcomes. Follow-up occurs eight weeks post-intervention. Values at follow-up, adjusted for baseline, will be compared between randomised groups. This study will provide much needed evidence on the effects of providing information about the genetic and phenotypic risk of T2D. Importantly, it will be among the first to examine the impact of genetic risk information using a randomised controlled trial design, a population-based sample, and an objectively measured behavioural outcome. Results of this trial, along with recent evidence syntheses of similar studies, should inform policy concerning the availability and use of genetic risk information. Current Controlled Trials ISRCTN09650496
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发表时间: 2004-01-01
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DOI: 10.1038/nature01626
发表时间: 2003-04-24
期刊: NATURE
影响因子: 64.8
作者:
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