- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505134
Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements
Exploring the Influence of GLP-1 Medications on External Food Cue Reactivity and Resultant Food Choice and Intake
The purpose of this randomized control trial is to compare how food cravings, food selection, and food consumption change in response to frequent food advertisements compared to non-food advertisements in adults taking GLP-1 (weight loss) medications. The primary question we aim to answer is: do GLP-1 medications reduce an individual's vulnerability to external triggers that drive food cravings and consumption?
Participants will:
- report daily food consumption for a total of 10 days,
- receive eight daily prompts to view food or non-food related advertisements, and respond to a short 9-question survey for 7 days,
- answer several questionnaires,
- and complete two in-person visits to complete a virtual reality food selection task.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18+) with overweight or obesity (BMI >25 kg/m2)
- On an injectable form of tirzepatide GLP-1 medication at a minimum dose of 7.5 mg, taking it as prescribed by their doctor
- Not currently taking an incretin-based medication at baseline other than the GLP-1 medication
- Fluent in English
Exclusion Criteria:
- Do not have consistent access to a smart phone that can access the study software
- Diagnosed with cognitive or physical disability or epilepsy
- Adults taking a compound GLP-1
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Food advertisement group
Advertisements viewed daily by this group will be food and/or beverage products
|
Videos and images of food and beverage advertisements from popular brands and/or restaurants
|
|
Placebo Comparator: Tech advertisement group
Individuals in this group will only receive tech-related advertisements daily
|
Video and photo advertisements of popular tech tools
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean food cue reactivity scores in the afternoon
Time Frame: 7-day period of all afternoon survey responses
|
Average scores of craving levels for each group following afternoon advertisement viewing sessions
|
7-day period of all afternoon survey responses
|
|
Mean food cue reactivity scores in the morning
Time Frame: 7-day period of all morning survey responses
|
Average scores of craving levels for each group following morning advertisement viewing sessions
|
7-day period of all morning survey responses
|
|
Mean food cue reactivity scores in the evening
Time Frame: 7-day period of all evening survey responses
|
Average scores of craving levels for each group following evening advertisement viewing sessions
|
7-day period of all evening survey responses
|
|
Mean food cue reactivity scores overall
Time Frame: 7-day period of all survey responses
|
Average scores of craving levels for each group over all viewing sessions
|
7-day period of all survey responses
|
|
Energy density of consumed foods
Time Frame: 7 days
|
The energy density profile of foods consumed each day
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in energy density of foods selected in the virtual buffet
Time Frame: Baseline and 7 days
|
Baseline and 7 days
|
|
|
Changes in food noise since being on medication questionnaire
Time Frame: Baseline
|
Questionnaire assessing various aspects of food noise at present compared to before the medication
|
Baseline
|
|
Changes in reasons for purchasing foods questionnaire
Time Frame: Baseline
|
A questionnaire that assesses how five factors impact purchasing choices, and how the main factors have changed between prior to starting the medication and after.
|
Baseline
|
|
Individual Food Cue Responsiveness--Trait
Time Frame: Baseline
|
Baseline
|
|
|
Change in brand familiarity, liking, and/or craving
Time Frame: Baseline and 7 days
|
A questionnaire that measures the familiarity, liking, and craving of each brand the participant will be exposed to (baseline) or has been exposed to (after intervention).
|
Baseline and 7 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00028881
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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