A Pilot Study to Assess the Impact of Exposure to Popular... | NCT05001633

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

NCT05001633

Sponsor

University College, London

Status

Unknown status

Last Update Posted

May 17, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

modified media content paradigm
control

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 9, 2021Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jul 19, 2021

First Submission Date that Met QC Criteria

Aug 5, 2021

First Posted Date

Aug 12, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	modified media content experience	Behavioral: modified media content paradigm
Control	Active Comparator	media content experience	Behavioral: control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified media content paradigm	Behavioral	media content	Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not based on self-representation of gender identity

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Adrian C Brown, PhD	Contact	02076796308	46308	a.c.brown@ucl.ac.uk
Alisia Carnemolla, PhD	Contact	02076796308	46308	a.carnemolla@ucl.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University College London Hospital	Recruiting	London			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided