None listed
Conditions
Brief summary
This pilot RCT study aims to assess the preliminary effectiveness, feasibility and acceptability of a telehealth Medical Nutrition Therapy (MNT) model of care (Diabeating Nutrition) delivered by dietitians for adults with type 2 diabetes (T2D) using GLP-1 RAs medication over 6-months, within the Hunter, NSW. Adults with T2D that are about to commence, currently using or previously used GLP-1 RA medication of primary care practices participating in the Diabetes Alliance Program Plus or registered in the NDSS will be invited to participate. Adults will be randomised to either: 1) Diabeating Nutrition: personalised MNT plus usual care (intervention), 2) Usual care without MNT (wait-list control). Preliminary effectiveness will be evaluated using the primary outcome measure HbA1c. Feasibility and acceptability will be assessed by MNT appointment attendance rates and process evaluation survey responses respectively. Study findings will be used for the development of fully powered RCT.
Interventions
Intervention group (Diabeating Nutrition): Study participants will receive up to two hours of Medical Nutrition Therapy (MNT) from a dietitian (with any clinical experience) via telehealth technology over five appointments in a six-month period. MNT is nutrition-based treatment provided by a dietitian that uses nutrition counselling and education that is personalised to the needs of the individual attending the appointment. The appointment will be conducted by Healthdirect or another videoconferencing software that complies with the Australian Privacy Policy and legal requirements for managing medical data. In the rare occurrence that internet coverage is insufficient, the participant will instead receive a phone call from the dietitian to receive MNT. During the MNT appointment, the dietitian will use the participant’s Australian Eating Survey-Heart version report and review their current dietary intake. The dietitian will also assess how their GLP-1 RA medication is or has impacted their dietary intake. This dietary assessment and study developed resources will be used to guide goal setting, nutrition interventions and behaviour change that are specific to the dietary needs of the participant. A summary of the MNT appointment including action plans and relevant resources will be sent to the participant via email after the appointment within four working days. For the first and final MNT appointment, the dietitian will send the planned actions plans to the participant’s general practitioner via REDCap. Participant's progress with their nutrition goals will be assessed by their dietitian in follow-up MNT appointments which is used to assess the participant's adherence to the intervention. Michie’s behaviour change paradigm will be used as the underpinning theoretical framework for the MNT appointments. The paradigm proposes characteristics for behaviour change interventions based on three components: capability (C), opportunity (O) and motivation (M). Prior to the first and last MNT appointment, participants will complete the Personalised Nutrition Questionnaire to identify COM factors that impact on their ability to usually eat healthily.
Sponsors
Study design
Eligibility
Inclusion criteria
-Adult (18 years or older) -Confirmed type 2 diabetes diagnosis (by their general practitioner) -About to commence (within 3-months), currently using or have previously used (past 3-months) Glucagon-Like Peptide-1 (GLP-1) or a dual-acting GLP-1/Glucose-dependent Insulinotropic Polypeptide (GIP) medications including semaglutide or tirzepatide -Able to travel to The University of Newcastle, Callaghan Campus for in person assessments to be recorded -Have access to a device (e.g., laptop, smartphone) -Have internet access and an email account -Can read and understand English
Exclusion criteria
-Not diagnosed with type 2 diabetes -Diagnosed with stage 4 or 5 chronic kidney disease or any type of cancer -Not used GLP-1 or a dual-acting GLP-1/GIP medication in the past three months and does not intend on commencing -Are currently consulting with a dietitian -Are currently pregnant or breastfeeding -Have a blood disorder that affect HbA1c- thrombocytopenia, thalassemia and haemolytic anaemia