Identifying Changes in Food Behaviors Associated With Beginning GLP-1 Medication
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPenn State University
About this trial
In recent years, GLP-1 medications have become a widely employed approach by physicians to address weight concerns in patients and lead to weight loss. Little is known, however, about how these medications may alter an individual's attitude towards food, food reactivity, or the specific types and amounts of foods an individual will choose. The purpose of this study is to observe the changes an individual experiences in their relationship and reaction to food and in their food selection prior to or within the first two weeks of taking GLP-1 medication to after three months on the medication. The researchers of this study believe that an understanding of such changes can inform questions seeking to ensure maintenance of appropriate nutrient balance within individuals on weight loss medications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (18+) with overweight or obesity (BMI >25 kg/m2)
Not currently taking an incretin-based medication at baseline
Recently (within two weeks) prescribed a GLP-1, can be included if they have a obesity-related co-occurring condition (diabetes, hypertension, cardiovascular disease, dyslipidemia)
Have had no prior diagnosis of cognitive or physical disability, dyslexia, or epilepsy.
Disqualifiers
Adults (18+) without overweight or obesity
<18 years of age at time of testing
Adults not taking a GLP-1 Medication
Adults taking a compound GLP-1
Trial population
Participants will be identified from a list of medical patients prescribed GLP-1 medication by their physicians (located in offices near State College or Hershey, PA) and who volunteered to be contacted regarding studies they are eligible for.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
GLP-1 Medication Initiation
Other interventionOne visit before starting GLP-1 medication and one visit 3 months after. No other changes administered between visits.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change from Baseline in Total Weight of Food Selected in the VR Buffet at 3 Months
Time frame
Baseline and 3 months2
Change from Baseline in Total Calories of Food Selected in the VR Buffet at 3 Months
Time frame
Baseline and 3 months3
Change from Baseline in Energy Density of Food Selected in the VR Buffet at 3 Months
Time frame
Baseline and 3 months4
Change from Baseline in Variety of Food Selected in the VR Buffet at 3 Months
Time frame
Baseline and 3 monthsSecondary outcomes
1
Change in Baseline Weight Watchers Food Noise Score at 3 Months
Based on participant's answers to the WW Food Noise questionnaire; Scale of 1-5, 1 being strongly disagree and 5 being strongly agree; Higher scores mean more food noise
Time frame
Baseline and 3 months2
Change in Baseline 9-question External Food Cue Responsiveness Questionnaire Score at 3 Months
Answers are on a 1-4 scale with 1 being "Rarely" and 4 being "A lot"; higher scores suggest more external food cue reactivity
Time frame
Baseline and 3 months3
Change in Baseline Adult Eating Behavior Score at 3 Months
Answers on a 1-5 scale with 1 being "Strongly disagree" and 5 being "Strongly agree"; 8 subscales, high scores indicate greater expression of subscale measure
Time frame
Baseline and 3 months4
Change in Baseline Three-Factor Eating Questionnaire Score at 3 Months
Rated on a scale of 1-4 with 1 being "Definitely false" and 4 being "Definitely true"; 3 subscales, higher scales on each means greater expression of that behavior
Time frame
Baseline and 3 monthsOther outcomes
1
Change in Baseline BMI at 3 Months
Calculated from height and weight collected at the end of both sessions
Time frame
Baseline and 3 monthsSponsors and contacts
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Source ClinicalTrials.gov