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| Name | Class |
|---|---|
| Knownwell | UNKNOWN |
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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.
This study aims to evaluate the impact of GLP-1 receptor agonist (GLP-1RA) medications, specifically semaglutide and tirzepatide, on food cravings and diet quality among individuals diagnosed with overweight and obesity. Participants will be recruited through Knownwell Health clinical staff, who will refer eligible patients to the UCD research team for further information and screening.
At Knownwell Clinic, standard care for patients on GLP-1RA medications includes blood draws, blood pressure evaluations, body composition analysis (Seca), and indirect calorimetry testing. These procedures will be conducted at baseline (week 0), midpoint (weeks 8-12), and end of titration/max dose (week 24).
Participants will complete a series of virtual questionnaires on nutrition, eating habits, and diet quality, along with a 3-day food diary. Regular medical appointments will follow Knownwell Clinic's standards of care. Participants must procure their own GLP-1RA medication. This study adds questionnaires to assess: dietary quality (photo-based food records), hunger (hunger VAS survey) and food cravings (FCI-II) related to GLP-1RA use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | eligible patients who are prescribed semaglutide for their obesity-management |
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| Tirzepatide | eligible patients who are prescribed tirzepatide for their obesity-management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Behavioral | Participants will be provided electronic surveys at 3 timepoints throughout study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in USDA Healthy Eating Index-2015 (HEI) Score | Effect of GLP1 medications on Healthy Eating Index-2015. The scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines. | Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in weight in kilograms | Effect of GLP1 medications on weight (in kg) | 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) |
Inclusion Criteria:
Exclusion Criteria:
Pregnancy and Other Exclusions during Trial:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Knownwell | Needham | Massachusetts | 02492 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D015930 | Diet Records |
| D002153 | Calorimetry, Indirect |
| D001823 | Body Composition |
| D055105 | Waist Circumference |
| D001827 | Body Height |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Indirect Calorimetry | Other | Participants will receive indirect calorimetry at 3 time points throughout the study. |
|
| 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. |
|
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| Anthropometrics | Other | Participants will have their Height, weight, waist circumference, and calculated BMI performed at 3 time points throughout the study. |
|
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| Changes in resting metabolic rate (RMR) | Effect of GLP1 medications on resting metabolic rate, assessed by indirect calorimetry. | Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks) |
| Change in weight loss percentage | Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks) |
| Changes in body fat percentage | Measured by seca mBCA 554 bioelectrical impedance analysis | Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks) |
| Changes in skeletal muscle mass (lbs) | Measured by seca mBCA 554 bioelectrical impedance analysis | Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks) |
| Changes in visceral fat mass (L) | Measured by seca mBCA 554 bioelectrical impedance analysis | Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks) |
| Changes in segmental skeletal muscle mass (lbs) | Measured by seca mBCA 554 bioelectrical impedance analysis | Baseline, Midpoint (8-12 weeks), End of study (24 + 2 weeks) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D002151 | Calorimetry |
| D002623 | Chemistry Techniques, Analytical |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D001824 | Body Constitution |
| D010829 | Physiological Phenomena |
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D000067029 | Physical Appearance, Body |
| D006128 | Growth |
| D048788 | Growth and Development |