FINGER 2015.

Study characteristics
Methods	Study design RCT Total study duration 2009‐2014 Duration of follow‐up 24 months
Participants	Population description Cognitive performance at the mean level or slightly lower that expected for age Risk population description (if applicable) CAIDE of 6 points or higher and cognitive performance at the mean level or slightly lower that expected for age Baseline age Mean 69.3 years Setting of study Healthcare practices Inclusion criteria Age 60‐77, CAIDE > 6, 1 insufficient CERAD section Exclusion criteria Previously diagnosed dementia, suspected dementia, MMSE < 20, disorders affecting safe engagement, severe loss of vision, hearing or communicative ability, disorders preventing co‐operation, coincident participation in other intervention trial  Participants randomised Total: 1260 Intervention: 631 Control: 629
Interventions	Targeted domains Diet, physical exercise, cognitive training, social activities, management of metabolic and vascular risk factors Intervention description Diet: nutritionists, 3 individual sessions, 7‐9 group sessions/physical exercise training programme by physiotherapists at the gym, muscle strength (1‐3 x per week), aerobic exercise (2‐ 5x per week),/ cognitive training: 10 group sessions by psychologists and individual computerised training  form home or study site (72 sessions of 10‐15 minutes)/social activities through group meetings/management of metabolic and vascular risk factors/3 meetings with nurse and 3 with physician for measurements and recommendations for lifestyle management. Intervention timing 6 monthly assessments with study nurse. Nutrition: 3 individual and 7‐9 group sessions. Physical exercise: 1‐3/week muscle strength, 2‐5/week aerobic. Cognitive training: 10 group, 72 individual sessions. Intervention delivered by Nutritionists, physiotherapists, psychologists, and physicians Intervention duration 24 months Control group description Regular health advice
Outcomes	Outcomes relevant to this review Composite cognition score, defined by the use of a neuropsychological test battery Mini‐Mental State Examination Mortality Myocardial infarct events Stroke events Quality of life, defined by RAND‐36 (SF‐36) score Activities of daily living, assessed by using multiple ADL related questionnaires
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Computer‐generated allocation was done in blocks of four (two individuals randomly allocated to each group) at each site after baseline by the study nurse."
Allocation concealment (selection bias)	Low risk	Adequate concealment
Blinding of participants and personnel (performance bias) All outcomes	High risk	Personnel could not be blinded due to the nature of the intervention. Participants were blinded as much as possible
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors were blinded to study allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	95% complete outcome data, no indicators of selective drop out
Selective reporting (reporting bias)	Low risk	MMSE was reported as secondary outcome in protocol paper, though not published afterwards. The findings on the MMSE were made available to us by the study authors upon request.
Other bias	Low risk	No other sources of bias identified