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| Name | Class |
|---|---|
| St Vincent's Hospital Melbourne | OTHER |
| The University of Queensland | OTHER |
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An observational study of those who have been prescribed a GLP-1 agonist therapy (yet to commence), for either weight or diabetes management, and are willing to complete dietary records and questionnaires of behaviour and psychosocial health.
Forty individuals (20 for weight management, 20 for diabetes management) living in Australia who have been prescribed a GLP-1 agonist (no previous prescription or no use in the previous 6 months) will be recruited to participate over the initial 3 months of their treatment. Assessments will occur remotely (online) at baseline, 2 weeks, 1 month and 3 months. Optional body composition assessments will be provided at baseline and 3 months for those based in Melbourne, Australia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight management | Prescribed GLP-1 agonist therapy primarily for weight management | ||
| Type 2 diabetes | Prescribed GLP-1 agonist therapy primarily for glycemic management |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of recruitment | The rate of recruitment and the retention rate of participants completing the dietary assessment measures. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Energy intake | Assessed using Intake24 records for at least 2 days per timepoint | baseline, 2 weeks, 1 month, 3 months |
| Medication symptomology | Incidence of self-reported side effects |
| Measure | Description | Time Frame |
|---|---|---|
| Patient perspectives | Qualitative interview after end of the observation period | 3 months |
| Macronutrient intake | Proportion of carbohdyrate, fat, protein, alcohol and fibre intake assessed through dietary records |
Inclusion Criteria:
Exclusion Criteria:
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Individuals living in Australia who are intending to commence a GLP-1 prescription
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| Name | Affiliation | Role |
|---|---|---|
| Evelyn B Parr, PhD | Australian Catholic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Australian Catholic University | Fitzroy | Victoria | 3065 | Australia |
The data that support the findings of this study will be available from the corresponding author for a period of 36 months from publication, upon reasonable request for academic use. The data will not be made publically available, as it contains information that could compromise research participant consent.
36 months from date of publication
Reasonable requests of data for academic use will be considered. Requests can be made to the corresponding author of the publication. Data will not be made publicly available as it contains information that could compromise research participant consent.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| baseline, 1 month, 3 months |
| Medication use | Dosage | baseline, 1 month, 3 months |
| baseline, 2 weeks, 1 month, 3 months |
| Diet quality | Assessed using Healthy Eating Index for Australian adults (HEIFA) from diet records (Intake24) | baseline, 2 weeks, 1 month, 3 months |
| Meal timing | Daily eating window and meal timing | baseline, 2 weeks, 1 month, 3 months |
| Medication use | Timing of medication use | baseline, 1 month, 3 months |
| Retrospective subjective appetite | Assessed using adaptive visual analogue scales with appetite questions as per Flint et al 2020 and used by Ravussin et al 2025, scored between 0 to 100, with a higher score meaning higher appetite ratings | baseline, 1 month, 3 months |
| Treatment self-regulation | Assessed using Treatment Self-regulation Questionnaire, 15 questions which are scored between 1 (not at all) and 7 (completely true) in response to questions | baseline, 1 month, 3 months |
| Food cravings | Assessed using Control of Eating Questionnaire (COEQ), a 21 questionnaire survey with a 0-100 scale where higher responses indicate higher severity of food cravings. | baseline, 1 month, 3 months |
| Internalisation of weight bias | Assessed using Weight Bias Internalisation Scale-Modified (WBIS-M), which includes 11 questions that are answered on a 1 (strongly disagree) to 7 (strongly agree) scale, noting that 2 questions are reverse scored. | baseline, 1 month, 3 months |
| Intuitive eating | Assessed using Intuitive Eating Scale 3 (IES-3), including 12 questions with options from 1 (strongly disagree) to 5 (strongly agree) where the higher total score indicates higher intuitive eating (Tykla et al, Appetite, 2024) | baseline, 1 month, 3 months |
| Health-related quality of life | Assessed using Short Form-36 (SF-36) questionnaire, where 36 questions are asked regarding the previous 4 weeks. Questions are given a score between 0 to 100 depending, and the overall score is the average of all questions. | baseline, 1 month, 3 months |
| Well being | Quality of life assessed using WHO-5 well being index, including 5 questions scored from 0 (none of the time) to 5 (all of the time), where a higher total score indicates better quality of life. | baseline, 1 month, 3 months |
| Binge eating | Assessed using Binge eating scale, which includes 16 questions. The total score ranges from 0 to 46, with higher scores correlating with more frequent and severe binge eating behaviours. | baseline, 1 month, 3 months |
| Disordered eating behaviours | Assessed using Eating Disorders Examination Questionnaire (EDEQ) 6.0, using 28 questions which are scored on 4 sub-scales and a global score is generated as an average of the 4 sub-scales. A higher score indicates greater disordered eating behaviours. | baseline, 1 month, 3 months |
| Physical activity | Assessed using International Physical Activity Questionnaire (long), which is 27 questions which asks duration (minutes) and frequency (days) of physical activity measured in domains of: 1) Job-related; 2) Transportation; 3) Housework, house maintenance, caring for family; 4) Recreation, sport, and leisure-time; and 5) Time spent sitting. An overall score is calculated using responses to all questions, where a higher score equates to greater physical activity. | baseline, 1 month, 3 months |
| Dietary changes | Assessed using Australian Eating Survey Food Frequency Questionnaire (FFQ), which has 120-item with 15 supplementary questions. The FFQ is designed to collect information about dietary intake over the participants previous 3 months. | baseline, 3 months |
| Micronutrient intake | Proportion of micronutrient intake (i.e. including but not limited to sodium, calcium, iron, zinc, vitamins, etc) assessed through dietary records | baseline, 2 weeks, 1 month, 3 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |