Food is Medicine: an Australian trial of a medically tailored meals intervention on type 2 diabetes and heart disease outcomes in adults

Not Applicable

Recruiting

• Conditions: Type 2 diabetes; Heart disease; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Other diet and nutrition disorders; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12622000852752
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-16
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

* Adults (greater than or equal to 18 years of age)
* Clinically diagnosed T2D for at least 12 months
* Persistently high blood glucose levels, defined as:
- For those referred by clinics: measured HbA1c greater than or equal to 7.5% at their most recent clinical assessment AND at least one more clinically measured HbA1c greater than or equal to 7.5% within the past 12 months.
- For those referred by Trial Facts or meal delivery companies: self-reported difficulty maintaining ideal blood sugar control AND measured HbA1c greater than or equal to 7.5% at their most recent clinical assessment within the past six months.
* Have difficulty getting and eating nutritious foods, assessed based judgement of the healthcare provider or a short questionnaire.

Exclusion Criteria

* Unable or unwilling to provide informed consent.
* Not planning to stay within their home in Greater Sydney area in the next 7 months.
* Individuals who have had an episode of severe hypoglycaemia defined as having received glucagon, or required ambulance or emergency department visit for hypoglycaemia, or requiring assistance from another individual / third party for hypoglycaemia within the last 6 months.
* In hospice or palliative care
* Living in a facility that provides most or all their meals.
* Does not have freezers at home for storing study meals.
* Does not have a microwave for heating meals at home
* Existing medical conditions that severely limits dietary intake, requires individualised diets
* Those with active cancer, severe chronic kidney disease (stage 4 or worse), or heart failure
* Those with severe food allergies (but those with gluten or dairy intolerances can participate)
* Pregnant women
* People participating in any other lifestyle modification research trials
* For individuals referred from meal delivery companies: have not placed an order with the meal companies in the past 12 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified