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临床试验/NCT03153098
NCT03153098Unknown不适用

Physical Activity Promotion in Areas of Deprivation for Inactive Adults With Cardiovascular Disease (CVD) Risk: An Evaluation of Active Herts

University of East Anglia1 个研究点 分布在 1 个国家目标入组 739 人开始时间: 2016年1月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
739
试验地点
1
主要终点
Change in Physical activity from baseline

研究概览

简要总结

There is a high prevalence of inactive adults in the United Kingdom (UK), many of whom suffer from conditions such as diabetes, cardiovascular disease, and poor mental health. These problems often co-exist more frequently in areas of higher socio-economic deprivation. There is an ongoing need to test the effectiveness, acceptability, and sustainability of community physical activity interventions. The Active Herts programme is a community physical activity programme aimed at inactive adults aged 16 and over who have one or more risk factors for cardiovascular disease (CVD) and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B ('Capability', 'Opportunity', 'Motivation' and 'Behaviour') model of behaviour change.

This evaluation will follow a mixed-methods longitudinal (baseline, and 3, 6 and 12 month follow-ups) pragmatic observational design. Two types of programme are being delivered, each in a different area. In one, group participants will receive a behaviour change technique booklet, consultations (baseline, and optional at 3, 6, and 12 months), a booster phone call (week 2), motivational text messages (weeks 3, 6, and 12), and signposting to 12 weeks of exercise classes. In the other 'enhanced delivery' group, participants will receive the same but the 12 weeks of exercise will be free and tailored to their needs, and there will be optional exercise 'buddies' available. An outcome evaluation will assess changes in physical activity as the primary outcome, and sporting participation, sitting, wellbeing, psychological capability, and reflective motivation as secondary outcomes. A process evaluation will use both one-to-one interviews and focus groups to explore the views of stakeholders, delivery staff, and participants over three phases (set-up, deviations in the delivery of the intervention, and looking back over the intervention). Economic evaluation will examine the costs of the Active Herts programme against the benefits gained in terms of reduced risk of morbidity from a range of chronic conditions.

This study will measure key drivers of physical activity using up to date behaviour change theory, allowing evaluation of not only whether physical activity has increased but also why. The research will inform the future development of a scalable intervention that can be more robustly tested in a randomised controlled trial.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • inactive adults and do less than 30mins of physical activity per week
  • aged 16 or over
  • resident of Hertfordshire boroughs, including Broxbourne, Hertsmere, Stevenage or Watford
  • Referred patients and clients may also have:
  • a long term medical condition such as type 2 diabetes, hypertension, high cholesterol etc.
  • a mild to moderate mental health condition such as anxiety, depression or stress
  • a history or family history of heart disease

排除标准

  • participants not able to give informed consent

结局指标

主要结局

Change in Physical activity from baseline

时间窗: 12 months

Assessed using the International Physical Activity Questionnaire (IPAQ)

次要结局

  • Change in perceptions of health from baseline(Short term (3 months), longer term (6 and 12 months))
  • Change in mental well-being from baseline(Short term (3 months), longer term (6 and 12 months))
  • Readiness to change behaviour(Short term (3 months), longer term (6 and 12 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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