Keyserling 2002.

Methods	3‐Arm parallel randomised controlled clinical trial (RCT) Randomisation ratio: 133 intervention:67 control Superiority design
Participants	African American women with type 2 DM Inclusion criteria:: African American women 40 years of age or older Diagnosis of type 2 DM Exclusion criteria: not stated Diagnostic criteria: type 2 DM defined as diagnosis of diabetes at 20 years of age or older with no history of ketoacidosis
Interventions	Number of study centres: 5 community health centres; 1 staff model health maintenance organisation; and 1 general medicine clinic at an academic health centre Treatment before study: not stated Intervention A: clinic‐based education + community‐based education. Clinic component consisted of individual counselling visits at months 1, 2, 3 and 4 The community component included 2 group sessions (90 minutes) and monthly telephone calls for the first 6 months; the second 6 months consisted of 1 group session and monthly telephone calls Intervention B: consisted of individual clinic‐based education with visits for the first 6 months, as described in intervention A. No further intervention was offered Control: Participants were mailed pamphlets from the ADA ("Staying Active, Healthy Eating", and "What is Non‐Insulin‐Dependent diabetes?") Provider: clinic nurse and peer counsellor
Outcomes	Outcomes reported in abstract of publication: Primary outcome(s): Physical activity (assessed by Clatrac accelerometer) Dietary intake (assessed by a series of three 24‐hour dietary telephone‐administered recalls) Glycosylated haemoglobin Lipids (total cholesterol and HDL) Weight Diabetes knowledge (15‐item adaptation of Diabetes Knowledge Scale) Diabetes health status (measured with 2 validated scales: Mental Well‐Being, and Social Well‐Being; each with 9 items) Secondary outcome(s): No specified primary and secondary outcomes
Study details	Run‐in period: not stated Study terminated before regular end: no
Publication details	Language of publication: English Funding: "Supported in part by a co‐operative agreement with the Centers for Disease Control and Prevention" Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "To determine whether a culturally appropriate clinic‐ and community‐based intervention for African‐American women with type 2 DM will increase moderate‐intensity physical activity"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: statistical consultant using random numbers from a random number generator
Allocation concealment (selection bias)	Low risk	Comment: sealed sequentially numbered envelopes
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Comment: because of the nature of the intervention, participants and providers unlikely to have been blinded
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: because of the nature of the intervention, participants and providers unlikely to have been blinded
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Low risk	Comment: lack of blinding unlikely to affect outcome
Blinding of outcome assessment (detection bias) Subjective outcomes	Unclear risk	Comment: does not say whether assessors delivering questionnaire on phone were blinded
Incomplete outcome data (attrition bias) Objective outcomes	Low risk	Comment: low attrition rate 10%; baseline comparability for those lost to follow‐up; reasons for attrition given for each group, roughly equal? No ITT done
Incomplete outcome data (attrition bias) Subjective outcomes	Low risk	Comment: low attrition rate 10%; baseline comparability for those lost to follow‐up; reasons for attrition given for each group, roughly equal? No ITT done
Selective reporting (reporting bias)	Unclear risk	Comment: protocol not seen
Other bias	Unclear risk	Comment: none