CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users

NCT06467604 | Active Not Recruiting

• 1 other identifier: 2184712
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the impact of GLP-1 receptor agonists, semaglutide and tirzepatide, on food cravings and diet quality in individuals with overweight or obesity. Over 24 weeks, up to 150 adult participants will be monitored using questionnaires and dietary records at 0, 12, and 24 weeks to measure changes in diet quality, disordered eating, food cravings, and hunger. This research, conducted with Seen Medical Group at Knownwell Health Clinic, seeks to fill the gap in literature on the dietary quality effects of GLP-1RAs.

Conditions

Obesity

Keywords

GLP-1; diet quality; weight loss; anti-obesity medication; food cravings

Outcome Measures

Primary Outcomes (1)

• Change in Food Craving Score

  Effect of GLP1 medications on food cravings measured by the food-craving inventory (FCI-II) questionnaire.The FCI-II is scored on a Likert scale from 1-5, with 1 being "Never," 5 being "Always/Almost every day."

  Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Secondary Outcomes (1)

• Change in USDA Healthy Eating Index-2015 (HEI) Score

  Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Other Outcomes (8)

• Changes in weight in kilograms

  Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

• Changes in waist circumference (cm)

  Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

• Changes in resting metabolic rate (RMR)

  Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks)

Study Arms (2)

Semaglutide

eligible patients who are prescribed semaglutide for their obesity-management

Behavioral: Surveys; Other: Indirect Calorimetry; Other: Body composition; Other: Anthropometrics

Tirzepatide

eligible patients who are prescribed tirzepatide for their obesity-management

Behavioral: Surveys; Other: Indirect Calorimetry; Other: Body composition; Other: Anthropometrics

Interventions

Surveys BEHAVIORAL

Participants will be provided electronic surveys at 3 timepoints throughout study.

Also known as: FCI-II, 3 day Food Diary, Hunger VAS, BED-7, HFSS 2-item food insecurity survey, MESA Neighborhood Healthy Food

Semaglutide; Tirzepatide

Indirect Calorimetry OTHER

Participants will receive indirect calorimetry at 3 time points throughout the study.

Semaglutide; Tirzepatide

Body composition OTHER

Participants will receive body scans using bioelectrical impedence seca mBCA 554 digital body composition analysis scale 3 time points throughout the study.

Also known as: Seca mBCA 554

Semaglutide; Tirzepatide

Anthropometrics OTHER

Participants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study.

Also known as: Waist circumference, Height, Weight

Semaglutide; Tirzepatide

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes male and female participants aged 18 to under 70 years diagnosed with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, sleep apnea, cardiovascular disease). They must have a history of at least one unsuccessful dietary effort to lose weight and be on a stable medication regimen affecting weight or diabetes outcomes for at least three months. Short courses of antibiotics and steroids are allowed. Participants must have maintained a stable weight (±5%) over the past three months, be under physician care, provide food diary data, have a smartphone or tablet for a food logging app, communicate in English, and provide informed consent.

You may qualify if:

• Male or female, age 18.0-\<70 years
• Obese (BMI greater than or equal to 30.0 kg/m2) or overweight (BMI greater than or equal to 27.0 kg/m2) with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease and history of at least one self-reported unsuccessful dietary effort to lose body weight will be recruited.
• On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
• Weight stable (+/- 5%) over previous 3 months
• Be under the care of a physician who will be responsible for managing participant's treatment regimen
• Willingness to provide food diary data throughout trial
• Access to a smartphone/tablet that can download the food logging application
• Willing and able to provide a valid email address for use in the study
• Be able to communicate (oral and written) in English
• Be able to provide informed consent

You may not qualify if:

• History of weight loss surgery
• History of major surgery within three months of enrollment
• Recent weight fluctuations exceeding 5 kg within a 3-month period preceding screening
• Use of systemic hormonal therapies (contraceptive medication is allowed)
• History of Type 1 or type 2 diabetes, HgbA1c ≥ 6.5% (gestational diabetes is allowed)
• Hemoglobinopathy that interferes with measurement of HbA1c
• Treatment with any GLP-1 Receptor Agonist medication(s) within 90 days of screening
• Significant kidney or liver disease, malnutrition, or any condition that, in the investigator's judgment, should exclude participation
• Documented chronic diseases including thyroid disease, kidney disease, active cancer, previous cardiovascular events, history or presence of chronic pancreatitis, or other gastrointestinal issues
• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
• Current cancer or cancer treatment, or history of cancer or cancer treatment within the last 3 years, excluding specific cases
• Diagnosis or strong clinical suspicion of eating disorders
• Background of significant active or unstable major depressive disorder (MDD) or any other severe psychiatric disorder within the past 2 years
• Lifetime history of a suicide attempt
• History of gastroparesis or other gut dysmotility syndrome

Sponsors & Collaborators

• University of California, Davis: lead
• Knownwell: collaborator

Study Sites (1)

Knownwell

Needham, Massachusetts, 02492, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Surveys and Questionnaires; Diet Records; Calorimetry, Indirect; Body Composition; Waist Circumference; Body Height; Weights and Measures

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Records; Organization and Administration; Health Services Administration; Calorimetry; Chemistry Techniques, Analytical; Biochemical Phenomena; Chemical Phenomena; Metabolism; Body Constitution; Physiological Phenomena; Body Size; Body Weights and Measures; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Physical Appearance, Body; Growth; Growth and Development

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 21, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 12, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)