Clinical trial NCT05001633: A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
Official title: A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: obesity
media content
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm parallel group
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Female adults aged 18-65 years.
2. Body Mass Index equal or greater than 30 kg/m2.
3. Weight stable at time of recruitment, defined as less than 5% variation in body weight over the preceding 3 months.
4. Proficient in written and spoken English.
5. Able to comply with study protocol.
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Type 1 and type 2 diabetes (in view of altered circulated gut hormone profiles and gustatory function).
2. Smoking (in view of the fact that smoking affects salivary cortisol).
3. Diagnosed with uncontrolled severe depression.
4. Diagnosed with uncontrolled psychiatric disorder.
5. Previous bariatric surgery.
6. Acute illness or chronic conditions that may impact HPA including Cushing syndrome.
7. 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).
8. Currently using glucocorticoids.
9. Pregnancy or lactation.
10. Elevated self-perceived stress as assessed by the Perceived Stress Scale.

Primary outcomes:
measure: Cortisol levels
timeFrame: up to 4 hours
Secondary outcomes:
measure: heart rate
timeFrame: up to 4 hours
measure: systolic and diastolic blood pressure
timeFrame: up to 4 hours
measure: blood glucose
timeFrame: up to 4 hours
measure: salivary hormones
timeFrame: up to 4 hours
measure: inflammatory cytokines
timeFrame: up to 4 hours
measure: dietary intake
timeFrame: up to 4 hours
measure: experience
timeFrame: up to 4 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital
Study officials:
References: