Clinical trial NCT07001553: Understanding Acute Dietary Changes After GLP-1 Agonist Treatment: The GLaD Feasibility Study
Official title: Understanding the Dietary Adjustments Following GLP-1 Agonist Treatment: The GLaD Feasibility Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity
Type 2 Diabetes Mellitus (T2DM)
Keywords: dietary behaviours
psychosocial health
Lead sponsor: Australian Catholic University
Sponsor class: OTHER
Collaborators: name: St Vincent's Hospital Melbourne
name: The University of Queensland
First posted: 2025-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals living in Australia who are intending to commence a GLP-1 prescription

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged 18+ years old
* Intending to commence a prescription for a GLP-1 agonist (may be dual agonist, i.e. Ozempic, Trulicity, Monjaro, or Saxenda) medication, with no use in the previous 6 months
* The primary reason for commencing the medication will be for diabetes or weight management
* Willing to participate in dietary recall and questionnaires

Exclusion Criteria:

* Aged under 18 years,
* used a GLP-1 agonist medication in the previous 6 months,
* unwilling or unable to provide dietary recalls
* non-English speaking.

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: 4 months
Secondary outcomes:
measure: Energy intake
timeFrame: baseline, 2 weeks, 1 month, 3 months
measure: Medication symptomology
timeFrame: baseline, 1 month, 3 months
measure: Medication use
timeFrame: baseline, 1 month, 3 months
Other outcomes:
measure: Patient perspectives
timeFrame: 3 months
measure: Macronutrient intake
timeFrame: baseline, 2 weeks, 1 month, 3 months
measure: Diet quality
timeFrame: baseline, 2 weeks, 1 month, 3 months
measure: Meal timing
timeFrame: baseline, 2 weeks, 1 month, 3 months
measure: Medication use
timeFrame: baseline, 1 month, 3 months
measure: Retrospective subjective appetite
timeFrame: baseline, 1 month, 3 months
measure: Treatment self-regulation
timeFrame: baseline, 1 month, 3 months
measure: Food cravings
timeFrame: baseline, 1 month, 3 months
measure: Internalisation of weight bias
timeFrame: baseline, 1 month, 3 months
measure: Intuitive eating
timeFrame: baseline, 1 month, 3 months
measure: Health-related quality of life
timeFrame: baseline, 1 month, 3 months
measure: Well being
timeFrame: baseline, 1 month, 3 months
measure: Binge eating
timeFrame: baseline, 1 month, 3 months
measure: Disordered eating behaviours
timeFrame: baseline, 1 month, 3 months
measure: Physical activity
timeFrame: baseline, 1 month, 3 months
measure: Dietary changes
timeFrame: baseline, 3 months
measure: Micronutrient intake
timeFrame: baseline, 2 weeks, 1 month, 3 months
Locations:
city: Fitzroy
country: Australia
facility: Australian Catholic University
state: Victoria
Study officials:
affiliation: Australian Catholic University
name: Evelyn B Parr, PhD
role: PRINCIPAL_INVESTIGATOR
References: