None listed
Conditions
Brief summary
This study will be a randomised, 12-week cross-over controlled design, the objective is to establish the feasibility, acceptability, and preliminary effectiveness of two dietary interventions (prepared meals and meal kits) vs a control condition (Coles/Myer vouchers) in community-based people living with schizophrenia who are overweight or obese. We hypothesise that both dietary interventions will be acceptable to participants (i.e., greater than or equal to 75% of participants will use prepared meals and meal kits for greater than or equal to 50% of the trial days), and that both dietary interventions will improve metabolic and other health-related outcomes from baseline to each 4-week follow-up. We also anticipate that prepared meals, given they require the least cognitive effort to use, will be the most acceptable option out of the three study arms, and Coles/Myer vouchers the least feasible and acceptable as participants in this arm receive neither specific foods, recipes nor prepared meals.
Interventions
The study will include 18 individuals with schizophrenia or schizoaffective disorder who will be randomised to either of the two intervention arms or control arm; prepared meals, meal kits or supermarket vouchers, each running for 4 weeks over a total of 12 weeks. Each participant will receive weekly, one meal per day in both 4-week intervention arms with similar numbers of calories/KJ per week. The intervention arms will not follow a specific dietary plan but will be healthy and nutricious. Al
The study will include 18 individuals with schizophrenia or schizoaffective disorder who will be randomised to either of the two intervention arms or control arm; prepared meals, meal kits or supermarket vouchers, each running for 4 weeks over a total of 12 weeks. Each participant will receive weekly, one meal per day in both 4-week intervention arms with similar numbers of calories/KJ per week. The intervention arms will not follow a specific dietary plan but will be healthy and nutricious. All participants will receive an educational brochure specifically designed for this study, at baseline including general information on healthy eating. Pre-prepared meals will take between 6-8 minutes to cook in a microwave and the meal kits will take approximately 20-30 minutes to prepare and cook the meal. Meal adherence will be measured using a dietitian guided self-reported daily checklist for record of consumption of prepared meals or meal kits as intended (amount, frequency, time of the day). There is no washout period between each arm.
Sponsors
Metro South Hospital and Health Service
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Aged between 18 and 64 years (inclusive) 2. Consumer Integrated Mental Health and Addiction (CIMHA) diagnosis of schizophrenia or schizoaffective disorder 3. BMI greater than or equal to 25kg/m2 at baseline 4. Have had less than 5% body weight increase or loss in the previous 3 months 5. Live in independent accommodation with access to a kitchen with relevant appliances and accessories 6. Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
Exclusion criteria
1. Acute psychiatric symptoms requiring immediate hospitalisation 2. Obesity induced by other endocrinologic disorder (e.g., Cushing Syndrome, untreated Hypothyroidism); 3. Previous surgical treatment of obesity 4. Current or prior history with risk of relapse, of a severe eating disorder 5. Any dietary allergies which preclude from safe consumption of provided meals or foods 6. Living with someone who prepares meals for them.
Outcome results
None listed