Table 1

Study questionnaire and procedures calendar

Theme	Measure	Variables/tests/questionnaires	Screening		Intervention				Follow-up
Theme	Measure	Variables/tests/questionnaires	Prescreening	Screening	Visit 1 (T0)	Visit 2 (3 weeks)	Visit 3 (8 weeks)	Visit 4 (12 weeks)	Visit 5 (26 weeks)	Visit 6 (52 weeks)
Visit label				V0	V1	V2	V3	V4	V5	V6
Time (weeks)			T-2 week	T-1 week	T0	3w	8w	12 w	26 w	52 w
Window			±1 w	±1 w	±1 w	±2 w	±2 w	±2 w	±2 w	±2 w
Intervention					A	A	A	A
Control					B			B
Inclusion	Pre-screening	Excel	X
	Short information	Flyer	X
	Screening for inclusion	Screening (verification)		X
	Presentation of the study	Information form		X
	Signature of informed consent	Consent form		X
	Allocation to treatment arm			X
Demographics	Sociodemographic data	Demographic			X
	Sociodemographic data	Demographic short				A,(B)	A,(B)	X	X	X
	Deprivation	DiPCare			X					X
Medical and psychometrics	Medical history	Health history			X
	New diagnoses, treatment change	Health history short				A,C,(B)	A,C,(B)	X	X	X
	Quality of life specific for diabetes	ADDQOL			X
	Depression	PHQ9			X	A,C,(B)	A,C,(B)	X	X	X
	Anxiety	GAD7			X			X	X	X
Diabetes	Diabetes history	Diabetes history			X
	Hypoglycaemia	Hypoglycaemia			X	A,C,(B)	A,C,(B)	X	X	X
	New diabetes complications, diabetes treatment changes	Diabetes History short				A,C,(B)	A,C,(B)	X	X	X
	The Summary of Diabetes Self-Care Activities	SDSCA			X			X	X	X
Smoking	Smoking history	Smoking history			X
	Smoking status and treatment	Smoking history short (NUI)				A,C,(B)	A,C,(B)	X	X	X
	Dependance scale	CDS-12			X				X	X
	Reasons to smoke	MRSS			X				X	X
	Withdrawal symptoms	CWS			X	A,B,C*	A,B,C*	X	X	X
Physical activity	Physical activity	IPAQ			X					X
Nutrition	Food Frequency Questionnaire	FFQ			X					X
Gender and psychosocial	Perceived Stress Scale	PSS			X				X	X
	Gender Composite measure (GENESIS-PRAXY)	BEM+ESSI			X
	Everyday discrimination scale	EDS			X					X
Physical examination	Vital signs	BP, puls			X	A,C	A,C	X	X	X
	Anthropometric measures	Weight, height, WC			X	A,C,(B)	A,C,(B)	X	X	X
	Exhaled CO measure	CO			X	A,C	A,C	X	X	X
Laboratory	Glycated haemoglobin	HbA1c			X			X	X	X
	Lipid profile	Chol tot, HDL, LDL, triglycerides			X			X	X	X
	Microalbuminuria (alb/creat)				X			X	X	X
	Creatinine				X			X	X	X
	Fasting glucose				X	A, C	A, C	X	X	X
	HsCRP				X			X	X	X
	TSH				X			X	X	X
	Biobank				X			X	X	X
Metabolic cohort	Microbiota (n=80)				C	C	C		C
Serious adverse events (SAE)	AE/SAE				X	A,C,(B)	A,C,(B)	X	X	X

X=group A+B, A=group A (intervention), B=group B (control), (B)=group B (control) by phone, C=microbiota cohort.
DIPCare: Deprivation in primary care using the French-validated DiPCare-Q94 SF-12: quality of life95 ADDQoL: Audit of Diabetes-Dependent Quality of Life96 PHQ-9: Patient Health Questionnaire for depression86 97 PHQ-15 for somatic symptoms86 97 GAD-7: Generalised Anxiety Disorder scale97
Hypoglycaemia: We will use the classification proposed by the American Diabetes Association to categorise hypoglycaemia.98 Severe hypoglycaemia is defined as ‘an event requiring assistance of another person to actively administer carbohydrate, glucagons or other resuscitative actions’. Documented symptomatic hypoglycaemia is defined as ‘an event during which typical symptoms of hypoglycaemia are accompanied by a measured plasma glucose concentration ≤3.9 mmol/L’. Asymptomatic hypoglycaemia is defined as an event not accompanied by typical symptoms of hypoglycaemia but with a measured plasma glucose concentration ≤3.9 mmol/L’. Finally, probable symptomatic hypoglycaemia is defined as ‘an event during which symptoms of hypoglycaemia are not accompanied by a plasma glucose determination’.
SEM-CD fv: Self-Efficacy to Manage Chronic Disease Scale-French version99 SDSCA: Summary of Diabetes Self-Care Activities85 NUI: Nicotine Use Inventory100 CDS-12: Cigarette Dependence Scale-12101 MRSS: Modified Reasons for Smoking Scale59 CWS: Cigarette Withdrawal Scale102 SEQ-12: Smoking Self-Efficacy Questionnaire103 IPAQ: International Physical Activity Questionnaire104 105 FFQ: Food Frequency Questionnaire validated for the French-speaking part of Switzerland106 PSS: Perceived Stress Scale107 GENESIS-PRAXY: gender composite score108 BEM: BEM Sex Role Inventory ESSI: ENRICHED Social Support Instrument109 EDS: Everyday Discrimination Scale.83
*Self-assessed at home byparticipants, red=primaryoutcome measures, green=secondaryoutcome measures, blue=exploratoryoutcome measures.
AE, adverse events; Alb/creat, urinary albumin:creatinine ratio; BP, blood pressure; Chol tot., total cholesterol; CO, carbon monoxide; HbA1c, glycosylated haemoglobin; HDL, high-density lipoprotein cholesterol; HsCRP, high-sensitivity C reactive protein; LDL, low-density lipoprotein cholesterol; TSH, thyroid-stimulating hormone; WC, waist circumference.