Trial of a Self-directed Behaviour Change Intervention for Physical Activity and Healthy Eating.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in mean daily physical activity level (PAL)
研究概览
简要总结
Many healthy lifestyle interventions have been developed to help people change their activity and diet, lose weight and thus reduce their risk of developing type 2 diabetes (T2DM) and cardiovascular disorders (CVD). However, these interventions often fail to engage their target audience, which undermines their effectiveness in changing behaviour and health outcomes.
The purpose of this study is to investigate the effectiveness of a self-directed, website-based intervention to promote physical activity and healthy dietary behaviours. The intervention frames health information from a novel perspective, which our previous work has indicated can help to promote interest in the health information and improve attitudes, self-efficacy and motivation towards physical activity and healthy dietary behaviours.
The intervention comprises a website of information resources and personal recording areas to set goals and monitor activity and diet, weekly emails and pedometers. In this trial we aim to see whether the intervention has any impact on people's physical activity and diet, as well as their risk of developing CVD and T2DM. The intervention will be compared with a control condition in which participants will be shown standard resources available on NHS websites. Overweight/obese (BMI 25 - 39.5) males and females aged 35-74 years will be recruited from the community. The active intervention will last 6 weeks (during this period participants will receive weekly emails from the research team) and there will be a 6-week follow-up phase (in which participants will still have access to the website but contact from the research team). Activity, diet, disease risk markers and psychological antecedents of behaviour will be assessed at baseline, post-intervention (6-weeks) and post follow-up (12- weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to give informed consent to participate in the study.
- •Male or female and aged between 35-74 years.
- •Defined as overweight or obese, i.e. BMI>25kg/m
- •Able to travel to the university for assessment days.
排除标准
- •Individuals who are not fluent in the English language, and who do not have access to and do not regularly use the internet and an email account.
- •Individuals diagnosed with coronary heart disease, chronic kidney disease, type 2 diabetes, stroke, heart failure, severe hypertension (BP>180/110mmHg) and peripheral arterial disease.
- •BMI>40kg/m2 (morbidly obese).
- •Currently using weight loss drugs or other medication that can affect weight.
- •Any reported recent (i.e. last 6 months) shift (>5%) in body mass or large change in habitual lifestyle.
- •Individuals unable to change their physical activity (e.g. through disability).
- •Current (pre-baseline) or recent (i.e. last 2 months) participation in another research trial or lifestyle supportive intervention or referral.
结局指标
主要结局
Change in mean daily physical activity level (PAL)
时间窗: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Mean daily physical activity level (PAL) will be assessed using accelerometers (BodyMedia, worn on the upper arm), worn for a continuous 7-day period, being removed during this time only for water-based activities such as showering or swimming. The accelerometers gather minute by minute total energy expenditure (TEE) data, which will be used to calculate PAL (PAL = TEE/BMR, where BMR = basal metabolic rate, to be calculated using the Schofield equation).
Change in mean daily energy intake (EI)
时间窗: Baseline, 6 weeks and 12 weeks after starting the intervention/control period
Mean daily energy intake (EI) will be assessed using 3-day weighed food diaries, incorporating 2 week days and 1 weekend day .
次要结局
- Fasting plasma glucose concentration(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Fasting plasma insulin concentration(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Fasting total cholesterol concentration(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Fasting LDL cholesterol concentration(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Fasting HDL cholesterol concentration(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- C-reactive protein (CRP) concentration(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Fasting triglyceride concentration(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Blood pressure(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Body mass index (BMI)(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Waist circumference(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Quality of diet(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Motivation for healthy eating(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Motivation for physical activity(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Self-efficacy for physical activity and healthy eating(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
- Self-efficacy for healthy eating(Baseline, 6 weeks and 12 weeks after starting the intervention/control period)
研究者
Elisabeth Grey
Principal investigator
University of Bath