The effect of Produce Prescription on health among adults with type 2 diabetes – a randomised controlled trial

Not Applicable

• Conditions: Diabetes; Diet and Nutrition - Other diet and nutrition disorders; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12624000680561
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-28
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Adults (greater than or equal to 18 years of age).
-Clinically diagnosed type 2 diabetes (T2D) for at least 12 months.
-Persistently high blood glucose levels, defined as self-reported or observed difficulty maintaining ideal blood sugar control AND at least one measured HbA1c greater than or equal to 7.5% within the past 6 months.
-Experiencing food insecurity as ascertained by a 6-item questionnaire or experiencing financial hardship ascertained by a 4-item questionnaire.

Exclusion Criteria

-Unable or unwilling to provide informed consent.
-Not living within the distribution zone of the study food supplier
-Planning to move away from the Greater Sydney area in the next 7 months.
-Living in a hospice or receiving palliative care
-Living in a facility that provides meals.
-Unable to receive food deliveries.
-lacking sufficient equipment (i.e., a refrigerator and hot plate/oven or stove or microwave) for food storage and preparation.
-Lacking anyone in the household (including the participant) able to prepare meals.
-Existing medical conditions such as severe food allergies that strictly limits dietary intake or requires individualised diets. (but those with gluten or dairy intolerances can participate)
-Those with active cancer or severe chronic kidney disease (need for dialysis).
-Pregnant people
-People participating in any other lifestyle modification research projects
-Self-identify as not being able to read and speak English.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate HbA1c, comparing intervention to control.[Pathology lab blood test. Baseline, 13 weeks and 26 weeks (primary timepoint) post-baseline.]