None listed
Conditions
Brief summary
Unhealthy dietary patterns including high intakes of sodium, refined carbohydrates, processed and red meat, and low intakes of fruits, vegetables, wholegrains, nuts and legumes, and fibre are leading risk factors for noncommunicable diseases such as type 2 diabetes. Eating a healthy diet is fundamental to the management of type 2 diabetes, but this can be particularly challenging for those who struggle with food security. Current clinical practice based on providing dietary counselling alone is inadequate if individuals are unable to access and prepare the foods and meals recommended. ‘Food is Medicine’ programs aim to integrate nutrition interventions into the health care system to help improve the clinical population’s diet and complement pharmacologic treatment of diseases. ‘Produce prescription’ (Produce Rx) is one such approach, in which healthy foods are subsidised or provided free-of-charge to patients as part of a health care intervention. We will therefore conduct a randomised controlled trial of produce prescription in adults with type 2 diabetes (T2D) and ongoing hyperglycaemia who experience food insecurity, recruited from diabetes centres in large hospitals and General Practices (GP) in New South Wales, Australia, and through a community advertisement. As part of the intervention package, participants will receive produce prescription (a healthy food box delivered to their homes) and be provided with dietary consultations to encourage uptake of foods and support enhancement of the overall healthiness of their diets. Our goal is to investigate a real-world pragmatic produce prescription intervention that will be feasible to embed in the Australian healthcare system. We are testing a primary null hypothesis of no difference in the HbA1c between participants in the intervention (receiving produce prescription) and control group (usual care) over 26 weeks.
Interventions
Over 26 weeks, each intervention participant will receive a weekly healthy food box which will include plant-based core food groups (fruit, vegetables, nuts and seeds, and whole grains) as recommended by the Australian Dietary Guidelines while taking into account participants’ preferences, cost and seasonality of products. The amount (‘dose’) of healthy foods provided will cover ~50% of daily recommended intake for fruit, vegetables, whole grains, and nuts and seeds, for 5 days every week. Parti
Over 26 weeks, each intervention participant will receive a weekly healthy food box which will include plant-based core food groups (fruit, vegetables, nuts and seeds, and whole grains) as recommended by the Australian Dietary Guidelines while taking into account participants’ preferences, cost and seasonality of products. The amount (‘dose’) of healthy foods provided will cover ~50% of daily recommended intake for fruit, vegetables, whole grains, and nuts and seeds, for 5 days every week. Participants will also receive a booklet which contains healthy recipe ideas that use the foods for breakfast, lunch and dinner. The healthy food boxes will be purchased from existing home-grocery delivery companies. Intervention participants will also receive 3 phone consults (up to 30 minutes) with dietitians at week 2, 8 and 16, to encourage uptake of healthy food boxes and improvements in diet quality overall. Intervention participants will also receive a $50 voucher each at baseline, week 13 and week 26 (after completion of pathology data collection). Any changes to diabetes medication requirements will be at the discretion of their treating clinician and documented. All participants will also be advised to follow up with their own doctors closely throughout the study, and that they should contact their treating doctors if they experience hypoglycaemia (self-monitored blood glucose <3mmol/L) or hypoglycaemic symptoms. A hot line for the participants to call an accredited diabetes educator will also be made available to answer any urgent questions. To monitor adherence to the intervention, study staff who conduct the diet consultations will log the number of dietary counselling sessions with each participant and collect the responses to three routine questions related to healthy food box acceptability and uptake at week 2, 4 and 16. Participants will also be asked to complete a self-administered Process Evaluation questionnaire at week 13 and week 26 of the intervention which includes questions about the uptake of the healthy food boxes.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed