The ProActive trial protocol - a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766].

The ProActive trial protocol - a randomised controlled trial of the efficacy of a family-based, domiciliary intervention programme to increase physical activity among individuals at high risk of diabetes [ISRCTN61323766].
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DOI:
10.1186/1471-2458-4-48
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发表时间:
2004-10-18
期刊:
影响因子:
4.5
通讯作者:
Kinmonth AL
Kinmonth AL
中科院分区:
医学2区
文献类型:
--
作者:
Williams K;Prevost AT;Griffin S;Hardeman W;Hollingworth W;Spiegelhalter D;Sutton S;Ekelund U;Wareham N;Kinmonth AL

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肥胖和与久坐生活相关的疾病的患病率日益增加,构成了一个主要的全球公共卫生问题。虽然以前对增加体力活动的干预措施的评估涉及已患有疾病的社区或个人,但对针对有疾病风险的个人的干预措施给予的关注较少。 ProActive 旨在评估基于理论、证据和家庭的干预计划的有效性,以增加久坐人群的体力活动,这些人群被定义为因父母有糖尿病家族史而面临风险的人群。使用初级保健糖尿病或家族病史登记册招募了 365 名年龄在 30-50 岁之间的个体,并对其活动水平进行了筛查。参与者被中央随机分配到三个干预计划:简短的书面建议(对照组),或基于心理的行为改变计划,通过电话(远程组)或在家里面对面提供,为期一年。协议驱动的干预计划由训练有素的促进者提供,旨在通过引入和促进一系列自我调节技能(例如目标设定)来支持身体活动的增加。主要结果是白天能量消耗及其与静息能量消耗的比率,使用单独校准的心率监测在基线和一年内进行测量。次要指标包括个人和家庭活动的自我报告、行为改变的心理调节因素、生理和生化相关性、可接受性和成本,在基线、六个月和一年时进行测量。治疗分析的主要目的是在随机分组后一年对各组进行比较。对糖尿病发病率影响的估计将使用使用类似措施的平行十年队列研究的数据进行建模。 ProActive 是一项干预计划的第一个功效试验,旨在通过初级保健促进特定高危人群的身体活动。干预方案以心理学理论和证据为基础;它引入并促进使用自我监管技能来支持行为改变和维持。该试验通过干预计划的仔细规范和质量保证、参与者的精确特征、长达一年的随访和身体活动的客观测量,解决了该领域的一系列方法学缺陷。 ProActive 将在 2005 年发布报告,估计这种方法可以在多大程度上帮助高危人群,这些人群可以从影响健康的行为改变中受益,并为未来的实用试验提供信息。
Increasing prevalence of obesity and disorders associated with sedentary living constitute a major global public health problem. While previous evaluations of interventions to increase physical activity have involved communities or individuals with established disease, less attention has been given to interventions for individuals at risk of disease. ProActive aims to evaluate the efficacy of a theoretical, evidence- and family-based intervention programme to increase physical activity in a sedentary population, defined as being at-risk through having a parental family history of diabetes. Primary care diabetes or family history registers were used to recruit 365 individuals aged 30–50 years, screened for activity level. Participants were assigned by central randomisation to three intervention programmes: brief written advice (comparison group), or a psychologically based behavioural change programme, delivered either by telephone (distance group) or face-to-face in the family home over one year. The protocol-driven intervention programme is delivered by trained facilitators, and aims to support increases in physical activity through the introduction and facilitation of a range of self-regulatory skills (e.g. goal setting). The primary outcome is daytime energy expenditure and its ratio to resting energy expenditure, measured at baseline and one year using individually calibrated heart rate monitoring. Secondary measures include self-report of individual and family activity, psychological mediators of behaviour change, physiological and biochemical correlates, acceptability, and costs, measured at baseline, six months and one year. The primary intention to treat analysis will compare groups at one-year post randomisation. Estimation of the impact on diabetes incidence will be modelled using data from a parallel ten-year cohort study using similar measures. ProActive is the first efficacy trial of an intervention programme to promote physical activity in a defined high-risk group accessible through primary care. The intervention programme is based on psychological theory and evidence; it introduces and facilitates the use of self-regulatory skills to support behaviour change and maintenance. The trial addresses a range of methodological weaknesses in the field by careful specification and quality assurance of the intervention programme, precise characterisation of participants, year-long follow-up and objective measurement of physical activity. Due to report in 2005, ProActive will provide estimates of the extent to which this approach could assist at-risk groups who could benefit from changes in behaviours affecting health, and inform future pragmatic trials.
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