ObesityNCT05001633
A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
A study testing modified media content paradigm in people with Obesity, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- modified media content paradigm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jul 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London
Adrian C Brown, PhD, a.c.brown@ucl.ac.uk
Alisia Carnemolla, PhD, a.carnemolla@ucl.ac.uk
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- modified media content paradigm, control
- Keywords
- obesity, media content
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified media content paradigmBehavioural
media content
controlBehavioural
media content experience
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | modified media content experience Receives: Behavioral: modified media content paradigm |
| Control | Active comparator | media content experience Receives: Behavioral: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol levels
To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.
Measured: up to 4 hours
Secondary outcomes (7)
heart rate
To characterise the impact of a modified media content on heart rate
Measured: up to 4 hours
systolic and diastolic blood pressure
To characterise the impact of a modified media content on blood pressure
Measured: up to 4 hours
blood glucose
To characterise the impact of a modified media content on blood glucose
Measured: 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
Measured: 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
Measured: 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
Measured: up to 4 hours
experience
To evaluate participants' experience through semi-structure interviews
Measured: up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start9 Jul 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm parallel group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001633
- Sponsor's protocol ID
- 135462
- Status last verified
- May 2022
- First submitted
- 19 Jul 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Impact of Exposure to Popular Media Content on Patients Living With Obesity
- ClinicalTrials.gov ID
- NCT05001633
- Acronym / sponsor ID
- 135462
- Conditions
- Obesity
- Keywords
- obesity, media content
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2-arm parallel group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: modified media content paradigmmodified media content experience |
| Control | Active comparator | Behavioral: controlmedia content experience |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified media content paradigmmedia content | Behavioural | Intervention |
| controlmedia content experience | Behavioural | Control |
Primary outcome
Cortisol levels
Time frame: up to 4 hours
To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.
7 secondary outcomes
heart rate
Time frame: up to 4 hours
systolic and diastolic blood pressure
Time frame: up to 4 hours
blood glucose
Time frame: up to 4 hours
salivary hormones
Time frame: up to 4 hours
inflammatory cytokines
Time frame: up to 4 hours
dietary intake
Time frame: up to 4 hours
experience
Time frame: up to 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified media content paradigm in people with Obesity, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian C Brown, PhD (02076796308 ext. 46308, a.c.brown@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol levels (time frame: up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.