A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity

Not Applicable

• Conditions: Obesity
• Interventions: Behavioral: control; Behavioral: modified media content paradigm

• Registration Number: NCT05001633
• Lead Sponsor: University College, London

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 Timeline

• Study Start: 2021-07-09
• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	control	media content experience
Intervention	modified media content paradigm	modified media content experience

Primary Outcome Measures

Name	Time	Method
Cortisol levels	up to 4 hours	To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.

Secondary Outcome Measures

Name	Time	Method
experience	up to 4 hours	To evaluate participants' experience through semi-structure interviews
dietary intake	up to 4 hours	To characterise the impact of a modified media content on dietary intake through the use of an online recalling diary called Intake24
salivary hormones	up to 4 hours	To characterise the impact of a modified media content on salivary hormones - what hormones will be analysed will depend on the availability of assays and will be decided later on at the end of the study
heart rate	up to 4 hours	To characterise the impact of a modified media content on heart rate
systolic and diastolic blood pressure	up to 4 hours	To characterise the impact of a modified media content on blood pressure
blood glucose	up to 4 hours	To characterise the impact of a modified media content on blood glucose
inflammatory cytokines	up to 4 hours	To characterise the impact of a modified media content on inflammatory cytokines - what cytokines will be analysed will depend on the availability of assays and will be decided later on at the end of the study

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom