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

May 16, 2022 updated by: University College, London
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
modified media content experience
Behavioral: modified media content paradigm
media content
Active Comparator: Control
media content experience
Behavioral: control
media content experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 4 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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