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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: modified media content paradigm
* Behavioral: control


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2-arm parallel group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>modified media content experience | Behavioral: modified media content paradigm<br>* media content<br>|
| Active Comparator: Control<br>media content experience | Behavioral: control<br>* media content experience<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol levels | To characterise the effect of a modified media content upon cortisol secretion in people living with obesity. | up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | To characterise the impact of a modified media content on heart rate | up to 4 hours | 
| systolic and diastolic blood pressure | To characterise the impact of a modified media content on blood pressure | up to 4 hours | 
| blood glucose | To characterise the impact of a modified media content on blood glucose | up to 4 hours | 
| 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 | 
| 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 | 
| 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 | 
| experience | To evaluate participants' experience through semi-structure interviews | up to 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, media content