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Status unknownNCT05001633Updated May 17, 2022

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

An interventional study of modified media content paradigm and control in Obesity, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by University College, London · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Obesity

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Keywords

  • obesity
  • media content
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 20 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

University College, London is the lead sponsor of 647 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Browse University College, London studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention

    modified media content experience

    Behavioral: modified media content paradigm

  • Active comparator
    Control

    media content experience

    Behavioral: control

Interventions

  • Behavioralmodified media content paradigm

    media content

  • Behavioralcontrol

    media content experience

06

What researchers measure

Primary outcomes

  1. Cortisol levels

    To characterise the effect of a modified media content upon cortisol secretion in people living with obesity.

    Time frame: up to 4 hours

Secondary outcomes

  1. heart rate

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

    Time frame: up to 4 hours

  2. systolic and diastolic blood pressure

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

    Time frame: up to 4 hours

  3. blood glucose

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

    Time frame: up to 4 hours

  4. 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

    Time frame: up to 4 hours

  5. 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

    Time frame: up to 4 hours

  6. dietary intake

    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

  7. experience

    To evaluate participants' experience through semi-structure interviews

    Time frame: up to 4 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2021 (actual). Primary completion is estimated for Dec 2022, 17 months after the start.

Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 17 months is below that.

Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2021
First posted
Aug 12, 2021
StartActual
Jul 9, 2021
Primary completionEst.
Dec 31, 2022
CompletionEst.
Dec 31, 2022
Last update
May 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05001633
Lead sponsor
University College, London
Responsible party
Sponsor
First posted
Aug 12, 2021
Start date
Jul 9, 2021
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
May 17, 2022

Study contacts

Adrian C Brown, PhD
Contact
a.c.brown@ucl.ac.uk
02076796308 ext. 46308
Alisia Carnemolla, PhD
Contact
a.carnemolla@ucl.ac.uk
02076796308 ext. 46308

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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