NCT05001633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

July 19, 2021

Last Update Submit

May 16, 2022

Conditions

Obesity

Keywords

obesitymedia content

Outcome Measures

Primary Outcomes (1)

  • 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 (7)

  • heart rate

    up to 4 hours

  • systolic and diastolic blood pressure

    up to 4 hours

  • blood glucose

    up to 4 hours

  • salivary hormones

    up to 4 hours

  • inflammatory cytokines

    up to 4 hours

  • +2 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

modified media content experience

Behavioral: modified media content paradigm

Control

ACTIVE COMPARATOR

media content experience

Behavioral: control

Interventions

modified media content paradigmBEHAVIORAL

media content

Intervention
controlBEHAVIORAL

media content experience

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNot based on self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Adrian C Brown, PhD

CONTACT

02076796308a.c.brown@ucl.ac.uk

Alisia Carnemolla, PhD

CONTACT

02076796308a.carnemolla@ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will not know what group they are allocated to until the intervention is delivered.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 2-arm parallel group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 12, 2021

Study Start

July 9, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

GB(1)