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

• Sponsor: University College, London (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05001633
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.7
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: modified media content paradigm; Behavioral: control	N/A

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
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2-arm parallel group2-arm parallel group
• Masking: Single (Participant)
• Masking Description: Participants will not know what group they are allocated to until the intervention is delivered.
• Primary Purpose: Other
• Official Title: A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
• Actual Study Start Date: Jul 9, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention modified media content experience	Behavioral: modified media content paradigm; media content
Active Comparator: Control media content experience	Behavioral: control; media content experience

Outcome Measures

Primary Outcome Measures

1. 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

1. heart rate [up to 4 hours]

   To characterise the impact of a modified media content on heart rate

2. systolic and diastolic blood pressure [up to 4 hours]

   To characterise the impact of a modified media content on blood pressure

3. blood glucose [up to 4 hours]

   To characterise the impact of a modified media content on blood glucose

4. 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

5. 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

6. 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

7. experience [up to 4 hours]

   To evaluate participants' experience through semi-structure interviews

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University College London Hospital	London		United Kingdom

Sponsors and Collaborators

• University College, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University College, London
• ClinicalTrials.gov Identifier: NCT05001633
• Other Study ID Numbers: 135462
• First Posted: Aug 12, 2021
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University College, London: obesity; media content
• Additional relevant MeSH terms: Obesity

Study Results

No Results Posted as of May 17, 2022