Australian Catholic University
Fitzroy, Victoria, 3065, Australia
NCT Number: NCT07001553
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.
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Notify Me18 year and older
All sexes
Observational
Fitzroy, Victoria, 3065, Australia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 months
The rate of recruitment and the retention rate of participants completing the dietary assessment measures.
Time frame: baseline, 2 weeks, 1 month, 3 months
Assessed using Intake24 records for at least 2 days per timepoint
Time frame: baseline, 1 month, 3 months
Incidence of self-reported side effects
Time frame: baseline, 1 month, 3 months
Dosage
Time frame: 3 months
Qualitative interview after end of the observation period
Time frame: baseline, 2 weeks, 1 month, 3 months
Proportion of carbohdyrate, fat, protein, alcohol and fibre intake assessed through dietary records
Time frame: baseline, 2 weeks, 1 month, 3 months
Assessed using Healthy Eating Index for Australian adults (HEIFA) from diet records (Intake24)
Time frame: baseline, 2 weeks, 1 month, 3 months
Daily eating window and meal timing
Time frame: baseline, 1 month, 3 months
Timing of medication use
Time frame: baseline, 1 month, 3 months
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
Time frame: baseline, 1 month, 3 months
Assessed using Treatment Self-regulation Questionnaire, 15 questions which are scored between 1 (not at all) and 7 (completely true) in response to questions
Time frame: baseline, 1 month, 3 months
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.
Time frame: baseline, 1 month, 3 months
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.
Time frame: baseline, 1 month, 3 months
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)
Time frame: baseline, 1 month, 3 months
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.
Time frame: baseline, 1 month, 3 months
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.
Time frame: baseline, 1 month, 3 months
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.
Time frame: baseline, 1 month, 3 months
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.
Time frame: baseline, 1 month, 3 months
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.
Time frame: baseline, 3 months
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.
Time frame: baseline, 2 weeks, 1 month, 3 months
Proportion of micronutrient intake (i.e. including but not limited to sodium, calcium, iron, zinc, vitamins, etc) assessed through dietary records
Australian Catholic University
Other
Understanding the Dietary Adjustments Following GLP-1 Agonist Treatment: The GLaD Feasibility Study
Acronym: GLaD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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