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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001633
• Other study ID #: 135462
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2022
• Source: University College, London
• Contact: Adrian C Brown, PhD
• Phone: 02076796308
• Email: a.c.brown[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• modified media content paradigm
media content
• control
media content experience

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortisol levels	To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.	up to 4 hours
Secondary	heart rate	To characterise the impact of a modified media content on heart rate	up to 4 hours
Secondary	systolic and diastolic blood pressure	To characterise the impact of a modified media content on blood pressure	up to 4 hours
Secondary	blood glucose	To characterise the impact of a modified media content on blood glucose	up to 4 hours
Secondary	salivary hormones	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	up to 4 hours
Secondary	inflammatory cytokines	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	up to 4 hours
Secondary	dietary intake	To characterise the impact of a modified media content on dietary intake through the use of an online recalling diary called Intake24	up to 4 hours
Secondary	experience	To evaluate participants' experience through semi-structure interviews	up to 4 hours