Griffin 2014.

Study characteristics
Methods	Multiple behaviour change intervention and outcomes in recently diagnosed type 2 diabetes: the ADDITION‐Plus randomised controlled trial RCT (NA clusters and NA providers), conducted in 1) Patients were recruited from 34 general practices in the East of England. The majority of practices (n = 26) were participating in the intensive treatment arm of the ADDITION‐Cambridge trial. A further 8 practices were recruited to increase the participation of recently clinically diagnosed patients. The intervention was delivered over 1 year at the participants’ surgeries. 2) The intervention was delivered by 3 female trained lifestyle facilitators, who were not part of the general practice team. In United Kingdom. 2 arms: 1. Control (comparison group: intensive treatment) (control arm) and 2. Intervention (intervention group: intensive treatment plus facilitator‐led behaviour change intervention) (intervention arm)
Participants	Control arm N: 239 Intervention arm N: 239, NA, NA Diabetes type: 2 Mean age: 59.65 ± 13.40 % Male: 62.35 Longest follow‐up: 12 months
Interventions	Control arm: (comparison group: intensive treatment) 1) Audit and feedback 2) Case management 3) Clinician education 4) Patient education 5) Promotion of self‐management Intervention arm: (intervention group: intensive treatment plus facilitator‐led behaviour change intervention) 1) Audit and feedback 2) Case management 3) Clinician education 4) Patient education 5) Promotion of self‐management
Outcomes	Glycated haemoglobin Systolic blood pressure Diastolic blood pressure Low‐density lipoprotein Smoking status
Funding source	The trial is supported by the Medical Research Council (grant reference no. G0001164), the Wellcome Trust (grant reference no. G061895), National Health Service R&D support funding (including the Primary Care Research and Diabetes Research Networks) and National Institute of Health Research under its Programme Grants for Applied Research scheme (RP‐PG‐0606‐1259). The Primary Care Unit is supported by NIHR Research funds. ATP is supported by the NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College, London, UK. Bio‐Rad provided equipment for HbA1c testing during the screening phase.
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Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was central and independent using a partial minimisation procedure to balance stratifiers (age, sex and general practice; and within screen‐detected and clinically diagnosed subgroups: BMI, self‐reported smoking and medication adherence) between treatment arms.
Allocation concealment (selection bias)	Low risk	Randomisation was central and independent. Randomisation was undertaken independently of study co‐ordination or knowledge of or contact with participants or their data, other than the stratifiers.
Patient's baseline characteristics (selection bias)	Low risk	Baseline characteristics were similar in the 2 trial groups (Table 1).
Patient's baseline outcomes (selection bias)	Low risk	Table 4. Outcomes similar between groups.
Incomplete outcome data (attrition bias)	Low risk	According to Figure 1, 220 (92%) attended 1 year visit at clinical research facility in the control arm, while 224 (94%) did it in the intervention arm, but it is unclear if data were available for each outcomes (HbA1c, LDL and blood pressure) for all patients. For self‐reported smoking status (table 3), they had data for 222 participants in the control arm (7.1% missing) and 227 in the intervention arm (5.0% missing). See Figure 1 for reasons for loss, balanced between groups.
Blinding of participants and personnel (performance bias) and of outcome assessors (detection bias)	Low risk	All outcomes were objectively measured (HbA1c, SBP, DBP and LDL), even smoking status with cotinine validation (smoking was also subjectively self‐reported).
Selective reporting (reporting bias)	Low risk	Prospectively registered protocol (protocol first posted on May 2001, study started on October 2001). Results match protocol.
Risk of contamination (other bias)	Unclear risk	The control arm involved an intensive treatment intervention also included in the intervention arm. Quote: "There may have been limited scope for additional benefit among ADDITION‐Plus patients, who were already receiving intensive treatment, including theory‐based educational materials and lifestyle advice on all the target behaviours by the primary care team."
Other bias	Low risk	None identified.