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

NCT07001553 | Completed

• 1 other identifier: 2025-4090H
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes Mellitus (T2DM)

Keywords

dietary behaviours; psychosocial health

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruitment

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

  4 months

Secondary Outcomes (3)

• Energy intake

  baseline, 2 weeks, 1 month, 3 months

• Medication symptomology

  baseline, 1 month, 3 months

• Medication use

  baseline, 1 month, 3 months

Other Outcomes (17)

• Patient perspectives

  3 months

• Macronutrient intake

  baseline, 2 weeks, 1 month, 3 months

• Diet quality

  baseline, 2 weeks, 1 month, 3 months

Study Arms (2)

Weight management

Prescribed GLP-1 agonist therapy primarily for weight management

Type 2 diabetes

Prescribed GLP-1 agonist therapy primarily for glycemic management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals living in Australia who are intending to commence a GLP-1 prescription

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Australian Catholic University: lead
• St Vincent's Hospital Melbourne: collaborator
• The University of Queensland: collaborator

Study Sites (1)

Australian Catholic University

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Evelyn B Parr, PhD

  Australian Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 3, 2025
• Study Start: May 28, 2025
• Primary Completion: January 7, 2026
• Study Completion: January 7, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 36 months from date of publication
• Access Criteria: 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.

Locations

AU (1)