Weber 2012.

Methods	RCT of parallel‐group design (pilot trial)
Participants	Included outpatients who were over 45 years of age with established or previous atherothrombotic CVD occurring in the past 10 years and who were at high CVD risk. The patients also had to have at least one of the following risk factors: diabetes mellitus, hypertension, smoking, dyslipidaemia family coronary artery disease history, asymptomatic carotid disease or BMI > 25 Exclusion criteria: neurocognitive or psychiatric conditions, pregnant or lactating women, patients with hepatic impairment or renal insufficiency, and patients with a life expectancy of less than 6 months (e.g. those with metastatic malignancies) 122 patients randomised; mean age 63 years; 66% men
Interventions	Pilot of the BALANCE trial Patients were randomised in a 1:1:1 ratio to receive one of 3 dietary interventions (A, B or C) Group A Joined the Brazilian Cardioprotective Diet Program, which involves a Brazilian version of an accessible dietary therapy for cardiovascular diseases and weekly counselling with dieticians. The main difference between the Brazilian Cardioprotective Diet Program and the usual dietary therapy (groups B and C) was the consideration of energy density. The Brazilian Cardioprotective Diet Program helped the patients to avoid high energy density foods (> 1 kcal/g), thus allowing them to eat more and consume fewer calories. As they made the right food choices, they felt less restricted, aiding in the improvement of adherence. The Brazilian Cardioprotective Diet Program features nutritional recommendations that are feasible for the Brazilian population, allowing for the easy access and full use of foods, in addition to the prioritisation of regional foods that are culturally accepted by the patients (rice, bean, soy oil, and Brazilian fruits and vegetables). Patients in Group A attended weekly in‐person sessions with dietitians either by phone or in a gourmet shop. During attendance at the gourmet shop, the patients received tips for eating in restaurants, instructions on label reading and a list of typical Brazilian recipes that were adjusted for nutrients and energy densities. Group B Received the dietary therapy that was proposed by the Brazilian guidelines for cardiovascular diseases and also attended weekly counselling sessions with dietitians. This diet had the same nutrient profile as that which was presented in Group A but was customised by the integration of typical Mediterranean foods (e.g. olives, olive oil, chestnuts, walnuts, almonds, hazelnuts, peanuts and cold water fish). Group B received weekly sessions that were conducted in person or by telephone. Group C Received the same dietary intervention as Group B, but the patients were counselled monthly in person The nutrient profiles of the 3 diets were based on the Brazilian guidelines for cardiovascular disease treatment. The diets contained 50% to 60% of energy from carbohydrates, 15% from proteins and 25% to 35% from fats. In addition, 20 g to 30 g/day of fibre and 2000 mg/day of sodium were recommended. The concentrations of saturated, monounsaturated and polyunsaturated fatty acids were 7%, 20% and 10%, respectively. The total dietary energy intake was adjusted only for patients with a baseline BMI > 25 kg/m². The first nutritional session lasted for 60 minutes. The follow‐up counselling sessions lasted for 30 minutes once the teaching and nutrition goals were reviewed. The phone interviews lasted approximately 15 minutes and included just the time that was necessary to assess the 24‐hour dietary recall. Follow‐up 12 weeks
Outcomes	SBP, DBP
Notes	Used Groups A and B as comparators in this review due to the same number of contacts, Group B representing the Mediterranean diet and intervention group, Group A the comparison diet. Change in blood pressure and SD difference were provided in graphs. Values have been estimated from these to use in meta‐analyses.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Low risk	Allocation concealment was guaranteed by using sealed and opaque envelopes that were numbered sequentially
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not stated
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not stated
Incomplete outcome data (attrition bias) All outcomes	Low risk	2/42 and 2/41 lost to follow‐up in Groups A and B respectively with reasons provided
Selective reporting (reporting bias)	Low risk	Outcomes reported as stated
Other bias	Unclear risk	Insufficient information to judge

AF: Atrial Fibrillation; BMI: body mass index; CVD: cardiovascular disease; DBP: diastolic blood pressure; HDL: high‐density lipoprotein; HF: Heart Failure; HRT: hormone replacement therapy; HTN: Hypertension; IHD: ischaemic heart disease; ITT: intention‐to‐treat; LDL: low‐density lipoprotein; MI: myocardial infarction; MUFA: monounsaturated fatty acid; PAD: peripheral arterial disease; PUFA: polyunsaturated fatty acid; RCT: randomised controlled trial; RDA: recommended daily allowance; SBP: systolic blood pressure; SD: standard deviation; SFA: saturated fatty acid; T2DM: type 2 diabetes mellitus; VLC: very‐long‐chain; WHO: World Health Organization