Back to resultsA Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
Primary Purpose
Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
modified media content paradigm
control
Sponsored by
About this trial
This is an interventional other trial for Obesity focused on measuring obesity, media content
Eligibility Criteria
Inclusion Criteria:
- Female adults aged 18-65 years.
- Body Mass Index equal or greater than 30 kg/m2.
- 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.
Sites / Locations
- University College London HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
modified media content experience
media content experience
Outcomes
Primary Outcome Measures
Cortisol levels
To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.
Secondary Outcome Measures
heart rate
To characterise the impact of a modified media content on heart rate
systolic and diastolic blood pressure
To characterise the impact of a modified media content on blood pressure
blood glucose
To characterise the impact of a modified media content on blood glucose
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
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
dietary intake
To characterise the impact of a modified media content on dietary intake through the use of an online recalling diary called Intake24
experience
To evaluate participants' experience through semi-structure interviews
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05001633
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, media content
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-arm parallel group
Masking
Participant
Masking Description
Participants will not know what group they are allocated to until the intervention is delivered.
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
modified media content experience
Arm Title
Control
Arm Type
Active Comparator
Arm Description
media content experience
Intervention Type
Behavioral
Intervention Name(s)
modified media content paradigm
Intervention Description
media content
Intervention Type
Behavioral
Intervention Name(s)
control
Intervention Description
media content experience
Primary Outcome Measure Information:
Title
Cortisol levels
Description
To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.
Time Frame
up to 4 hours
Secondary Outcome Measure Information:
Title
heart rate
Description
To characterise the impact of a modified media content on heart rate
Time Frame
up to 4 hours
Title
systolic and diastolic blood pressure
Description
To characterise the impact of a modified media content on blood pressure
Time Frame
up to 4 hours
Title
blood glucose
Description
To characterise the impact of a modified media content on blood glucose
Time Frame
up to 4 hours
Title
salivary hormones
Description
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
Time Frame
up to 4 hours
Title
inflammatory cytokines
Description
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
Time Frame
up to 4 hours
Title
dietary intake
Description
To characterise the impact of a modified media content on dietary intake through the use of an online recalling diary called Intake24
Time Frame
up to 4 hours
Title
experience
Description
To evaluate participants' experience through semi-structure interviews
Time Frame
up to 4 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Not based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female adults aged 18-65 years.
Body Mass Index equal or greater than 30 kg/m2.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian C Brown, PhD
Phone
02076796308
Ext
46308
Email
a.c.brown@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Alisia Carnemolla, PhD
Phone
02076796308
Ext
46308
Email
a.carnemolla@ucl.ac.uk
Facility Information:
Facility Name
University College London Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian C Brown, PhD
Email
a.c.brown@ucl.ac.uk
First Name & Middle Initial & Last Name & Degree
Alisia Carnemolla, PhD
Email
a.carnemolla@ucl.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided
Learn more about this trial
A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
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