Skip to main content
OpenTrials
Completed

NCT Number: NCT07001553

Understanding Acute Dietary Changes After GLP-1 Agonist Treatment: The GLaD Feasibility Study

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Feasibility of recruitment

    Time frame: 4 months

    The rate of recruitment and the retention rate of participants completing the dietary assessment measures.

Secondary outcomes

  1. Energy intake

    Time frame: baseline, 2 weeks, 1 month, 3 months

    Assessed using Intake24 records for at least 2 days per timepoint

  2. Medication symptomology

    Time frame: baseline, 1 month, 3 months

    Incidence of self-reported side effects

  3. Medication use

    Time frame: baseline, 1 month, 3 months

    Dosage

Other outcomes

  1. Patient perspectives

    Time frame: 3 months

    Qualitative interview after end of the observation period

  2. Macronutrient intake

    Time frame: baseline, 2 weeks, 1 month, 3 months

    Proportion of carbohdyrate, fat, protein, alcohol and fibre intake assessed through dietary records

  3. Diet quality

    Time frame: baseline, 2 weeks, 1 month, 3 months

    Assessed using Healthy Eating Index for Australian adults (HEIFA) from diet records (Intake24)

  4. Meal timing

    Time frame: baseline, 2 weeks, 1 month, 3 months

    Daily eating window and meal timing

  5. Medication use

    Time frame: baseline, 1 month, 3 months

    Timing of medication use

  6. Retrospective subjective appetite

    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

  7. Treatment self-regulation

    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

  8. Food cravings

    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.

  9. Internalisation of weight bias

    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.

  10. Intuitive eating

    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)

  11. Health-related quality of life

    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.

  12. Well being

    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.

  13. Binge eating

    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.

  14. Disordered 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.

  15. Physical activity

    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.

  16. Dietary changes

    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.

  17. Micronutrient intake

    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

Sponsors and collaborators

Lead sponsor

Australian Catholic University

Other

Collaborators

  • St Vincent's Hospital Melbourne
  • The University of Queensland

Registry information

Official study title

Understanding the Dietary Adjustments Following GLP-1 Agonist Treatment: The GLaD Feasibility Study

Acronym: GLaD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 3, 2025
Registry last updated
Mar 2, 2026

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.

Published trials that share one or more normalized conditions with this study.