A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Cortisol levels
研究概览
简要总结
This study will explore the impact of exposure to popular media content on patients living with obesity. Findings from this study will provide new insights that will extend current understanding of exposure to media portrayal. This is a proof of principle pilot study that will evaluate the feasibility of recruitment, randomisation, assessment procedures and implementation of the intervention with the aim to facilitate the planning and the conduct of a full-scale randomised controlled trial.
详细描述
This study will explore the impact of exposure to popular media content on patients living with obesity. Findings from this study will provide new insights that will extend current understanding of exposure to media portrayal. This is a proof of principle pilot study that will evaluate the feasibility of recruitment, randomisation, assessment procedures and implementation of the intervention with the aim to facilitate the planning and the conduct of a full-scale randomised controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants will not know what group they are allocated to until the intervention is delivered.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female adults aged 18-65 years.
- •Body Mass Index equal or greater than 30 kg/m
- •Weight stable at time of recruitment, defined as less than 5% variation in body weight over the preceding 3 months.
- •Proficient in written and spoken English.
- •Able to comply with study protocol.
- •Willing and able to provide written informed consent.
排除标准
- •Type 1 and type 2 diabetes (in view of altered circulated gut hormone profiles and gustatory function).
- •Smoking (in view of the fact that smoking affects salivary cortisol).
- •Diagnosed with uncontrolled severe depression.
- •Diagnosed with uncontrolled psychiatric disorder.
- •Previous bariatric surgery.
- •Acute illness or chronic conditions that may impact HPA including Cushing syndrome.
- •Known or suspected history of HIV, Hepatitis B or C or other blood-borne diseases (in view of safety regulations regarding exposure to blood products).
- •Currently using glucocorticoids.
- •Pregnancy or lactation.
- •Elevated self-perceived stress as assessed by the Perceived Stress Scale.
结局指标
主要结局
Cortisol levels
时间窗: up to 4 hours
To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.
次要结局
- experience(up to 4 hours)
- dietary intake(up to 4 hours)
- salivary hormones(up to 4 hours)
- heart rate(up to 4 hours)
- systolic and diastolic blood pressure(up to 4 hours)
- blood glucose(up to 4 hours)
- inflammatory cytokines(up to 4 hours)