A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University College, London
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Cortisol levels
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants will not know what group they are allocated to until the intervention is delivered.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Intervention
modified media content experience
Intervention: modified media content paradigm (Behavioral)
Control
media content experience
Intervention: control (Behavioral)
Outcomes
Primary Outcomes
Cortisol levels
Time Frame: up to 4 hours
To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.
Secondary Outcomes
- 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)