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Table 2 Inclusion and exclusion Criteria for Project 1 screening and all intervention projects

From: Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose

Inclusion criteria

Exclusion criteria

Age 40 years or over and at least one of the below risk factors:

Body mass index (BMI) ≥30 kg/m2

Parent, sibling or child with T2DM

Personal history of coronary disease

Previous history of gestational diabetes

OR

Known impaired fasting glucose, impaired glucose tolerance and/or HbA1c NDH range

Not able to provide GP details i.e. not registered with a GP or unwilling for their GP to be contacted

Unable to give informed consent due to lack of capacity through severe mental health, learning difficulties or significant cognitive impairment

Self-reported conditions which could adversely affect the trial results or patient clinical wellbeing such as:

 i. Terminal illness.

 ii. Antipsychotic medication, which may affect glucose tolerance

 iii. High dose oral steroids [>4 weeks or >7.5 mg]

 iv. Active treatment for malignancy

 v. Stage IV renal impairment or ongoing renal dialysis

 vi. Pregnant or lactating

 vii. Stage IV NYHA cardiac failure

Taking part in any research study which involves a dietary or lifestyle change intervention [exceptions are participants in observational research studies] Participation in other research studies are assessed on an individual basis

Inability to attend or comply with the interventions or follow-up scheduling

Living with or related to someone in the programme team

Diabetes Prevention Mentors inclusion criteria

Age 18 years or over

Diagnosed with T2DM for ≥2 years

GP/clinician advice on health grounds that participant should not take part or be contacted

Not able to provide GP details, not registered with a GP or unwilling for their GP to be contacted

Unable to give informed consent due to lack of capacity through severe mental health, learning difficulties or significant cognitive impairment

Self-reported conditions such as:

 i. Terminal illness.

 ii. Active treatment for malignancy

 iii. Stage IV renal impairment or ongoing renal dialysis

 iv. Pregnant or lactating

 v. Stage IV NYHA cardiac failure