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

INTERVENTION: Over 26 weeks, each intervention participant will receive a weekly healthy food bo Xwhich 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 CONDITION: Diabetes; ; Diabetes Diet and Nutrition ‐ Other diet and nutrition disorders Metabolic and Endocrine ‐ Diabetes PRIMARY OUTCOME: Evaluate HbA1c, comparing intervention to control.[Pathology lab blood test. Baseline, 13 weeks and 26 weeks (primary timepoint) post‐baseline.] 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. SECONDARY OUTCOME: Blood lipids.[Pathology lab tests. Baseline, 13 weeks and 26 weeks post‐baseline.] Blood pressure.[Validated blood pressure monitor. Baseline, 13 weeks and 26 weeks post‐baseline.] Body weight [Validated body weight scale. Baseline, 13 weeks and 26 weeks post‐baseline.] C reactive protein.[Pathology lab tests. Baseline, 13 weeks and 26 weeks post‐baseline.] Diabetes distress.[Captured by validated questionnaire: Problem Areas In Diabetes ‐ 20 items (PAID‐20). Baseline and 26 weeks post‐baseline.] Diabetes self‐management.[Captured by validated questionnaire: Diabetes Management Experience Questionnaire (DME‐Q). Baseline and 26 weeks post‐baseline.] Diet quality.[Aus‐SDS (Australian Short Dietary Screener) and questions adapted from the Rapid Eating Assessment of Participants, Short Version v2 (REAP‐S). Baseline, 13 weeks and 26 weeks post‐baseline. ] Financial hardship.[Questionnaire adapted from Protocol for Responding to and Assessing Patient's Assets, Risks and Experiences (PRAPARE) and Household Income and Labour Dynamics in Australia (HILDA). Baseline and 26 weeks post‐baseline.] Food insecurity.[United States Department of Agriculture USDA 6‐item household food security survey Baseline, 13 weeks and 26 weeks post‐baseline.] Food/ medicine purchasing trade‐offs.[Two item questionnaire taken from the six‐item short form of the US Department of Agriculture’s Household Food Security Survey Module. Baseline and 26 weeks post‐baseline.] General emotional well‐being.[Captured by validated questionnaire: WHO‐5 Baseline and 26 weeks post‐baseline.] Generic health status. [Captured by validated questionnaire: EQ‐5D‐5L. Baseline and 26 weeks post‐baseline.] Glucose.[Pathology lab tests Baseline, 13 weeks and 26 weeks post‐baseline.] Liver function.[Pathology lab tests. Baseline, 13 weeks and 26 weeks post‐baseline.] Medication adherence.[Captured by validated questionnaire: Medication Adherence Questionnaire (MAQ). Baseline and 26 weeks post‐baseline.] Medication use.[Based on self‐report over the phone. Baseline, 13 weeks and 26 weeks post‐baseline. ]