Obesity
Conditions
Keywords
obesity, media content
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.
Interventions
BEHAVIORALmodified media content paradigm
media content
BEHAVIORALcontrol
media content experience
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants will not know what group they are allocated to until the intervention is delivered.
Intervention model description
2-arm parallel group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol levels | up to 4 hours | To characterise the effect of a modified media content upon cortisol secretion in people living with obesity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| experience | up to 4 hours | To evaluate participants' experience through semi-structure interviews |
| 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 |
Countries
United Kingdom
Contacts
Primary ContactAdrian C Brown, PhD
Backup ContactAlisia Carnemolla, PhD
Outcome results
None listed