None listed
Conditions
Brief summary
‘Food is medicine’ programs incorporate provision of healthy foods into the medical system to help improve population diets and complement pharmacologic treatment of non-communicable diseases. Healthy ‘Food Farmacy’ is one such approach, which allows physicians and other health professionals to prescribe healthy food for lower-income or food-insecure patients, in combination with nutrition education and related social support to synergistically improve health behaviour. This is a pilot healthy Food Farmacy trial that will recruit food-insecure patients with poorly-controlled type 2 diabetes (T2D) via physician consultations at hospital sites in Sydney. Participants will be prescribed food boxes comprising of healthy foods such as whole grains, fruits, vegetables, nuts/nut butters, and low-fat unsweetened dairy products; which will be provided to them weekly over 3 months. In addition, participants will be provided simple recipes as well as fortnightly dietary consultations on nutrition education and cooking tips. The primary outcome of interest in this pilot study is to understand the effects of the Food Farmacy intervention on dietary behaviour in patients. In addition, this trial will assess the feasibility and acceptability of the intervention by collecting feedback from key stakeholders. Finally, effects of the Food Farmacy on food security, clinical risk factors and household behaviours will be explored before and after the intervention.
Interventions
Each participant will receive a ‘prescription’ for healthy food boxes which meet Australian Dietary Guidelines and were developed specifically for this study. The participants will have healthy food boxes delivered to them weekly by the study food supplier for a period of 12 weeks. Orders will be placed by study staff at a delivery time convenient for the participant
and each participant will receive the same content. The prescription will also contain simple recipes using foods available in
Each participant will receive a ‘prescription’ for healthy food boxes which meet Australian Dietary Guidelines and were developed specifically for this study. The participants will have healthy food boxes delivered to them weekly by the study food supplier for a period of 12 weeks. Orders will be placed by study staff at a delivery time convenient for the participant and each participant will receive the same content. The prescription will also contain simple recipes using foods available in the healthy food boxes. In addition, the prescription will allow the participants to have fortnightly telephone appointments (up to 30-minutes) with trained accredited dietitian capable of offering behaviour change support, who will provide dietary advice, including a specific focus on how to store and cook the healthy foods provided to the participants.
Sponsors
The George Institute for Global Heath
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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) who have had clinically diagnosed type 2 diabetes for at least 6 months, which is poorly controlled (defined as measured HbA1c greater than or equal to 8% at their most recent clinical assessment). - Food insecure based on a two-item questionnaire. This two-item questionnaire is based on Questions 1 & 2 of the U.S. Household Food Security Survey and has been validated for use as a screening tool in the health care setting. - Live within the distribution zone of the study food supplier.
Exclusion criteria
- Unable or unwilling to provide informed consent. - Anyone not planning to stay within their home in Sydney area in the next 4 months. - On hospice or palliative care. - Living in a facility that provides meals. - Does not have refrigerators at home for storing study foods. - Existing medical conditions that may preclude participants from being able to complete data collection, or result in limited diets, including for example: active cancer, chronic kidney disease (stages 4-5), and coeliac disease. - Pregnant women, and if sexually active, not using regular contraception. - People participating in any other lifestyle modification research projects (for example, the Pasifika Preventing Diabetes Programme, a concurrent trial underway in the western Sydney area). - Another household member already participating in the study
Outcome results
None listed