Kattelmann 2009.

Methods	Randomised controlled clinical trial (RCT): 2 groups: intervention and 'usual care' control group Randomisation ratio: 1:1 Superiority design
Participants	Inclusion criteria: Northern Plain Indians from the Cheyenne River Sioux Reservation (self‐report) Age 18‐65 years Diagnosed with type 2 diabetes (diagnosed previously by personal physician) Agreed not to consume over‐the‐counter supplements during the study period Agreed not to consume alcohol over the study period Exclusion criteria: If candidate had self‐reported compromised renal function If candidate had microalbuminuria (urinary albumin > 30 mg/24 h). This was determined through urinalysis at recruitment visit Participants were excluded from study if they were entered for alcohol treatment at any point Diagnostic criteria: previous diagnosis by personal physicians
Interventions	Number of study centres: 1 Treatment before study: N/A Intervention: Intervention consisted of six 2‐hour‐long group (5‐9 participants) nutrition education lessons, based on the Medicine Wheel Nutrition Model. This model uses the Medicine Wheel diagram to promote a diet patterned according to the traditional consumption of macronutrients for Northern Plains Indians (approx. 25% protein, 25% fat, 50% carbohydrate). The 6 class sessions were on the following topics: The Medicine Wheel Model for Native Nutrition/Individualized meal plans; self‐monitoring of eating; self‐monitoring of physical activity; changing the environment to promote food choices; eating at home: food preparation techniques; and problem solving After each lesson, participants were given the opportunity to attend a group support session called a Talking Circle. This is a method of intragroup communication in many Insian communities Each participant had total energy requirement estimated and was then provided an individualised meal plan built upon the 4 meal components of the Medicine Wheel Nutrition Model Control: Control group received only the standardised dietary education provided by personal healthcare providers at the local Indian Health Services Hospital. At the time of the study, this hospital did not have a registered dietician on staff. Participants in the control group were offered the same classes Provider: Group education sessions were run by a registered dietician and a tribal member, who was trained in the curriculum
Outcomes	Assessed at baseline and at 6 months (after intervention): Weight BMI HbA1c Fasting serum glucose concentrations Total cholesterol Low‐density lipoprotein cholesterol High‐density lipoprotein cholesterol Triglycerides Circulating insulin concentration Blood pressure (systolic and diastolic) Dietary intake (collected using 24‐hour recall by a registered dietician) Physical activity (assessed using the Cross‐Cultural Activity Participation Study (CAPS) physical activity survey) Satiety of diet (assessed using a rating scale designed to measure subjective satiety of the diet)
Study details	Run‐in period: unclear. Study took place from January 2005 to December 2005 Study terminated before regular end: no
Publication details	Language of publication: English Funding: not stated but does mention "Missouri Breaks Industries, a local native American owned company assisted with recruitment and transportation of participants to study visits" Publication status: peer‐reviewed journal
Stated aim of study	Quote from publication: "The objective of this study was to determine if Northern Plains Indians with type 2 diabetes mellitus who are randomized to receive culturally adapted educational lessons based on the Medicine Wheel Model for Nutrition in addition to their usual dietary education will have better control of their type 2 diabetes then a non‐intervention, usual care group who received only the usual dietary education from their personal providers"
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from publication: "randomised using a computer generated random number chart"
Allocation concealment (selection bias)	Unclear risk	Comment: not mentioned
Blinding of participants and personnel (performance bias) Objective outcomes	High risk	Quote from publication: "Project investigators were not blinded to the intervention" Comment: participants unlikely to have ben blinded because of the nature of the intervention
Blinding of participants and personnel (performance bias) Subjective outcomes	High risk	Comment: participants unlikely to have ben blinded because of the nature of the intervention
Blinding of outcome assessment (detection bias) Lab tests: Lipids, HBA1C	Unclear risk	Comment: does not say whether technicians or laboratory staff blinded
Blinding of outcome assessment (detection bias) Subjective outcomes	High risk	Comment: participants and project investigators not blinded
Incomplete outcome data (attrition bias) Objective outcomes	Unclear risk	Comment: does not state whether lost to follow‐up from intervention or control group; per‐protocol analysis, low attrition rate (92% completion rate)
Incomplete outcome data (attrition bias) Subjective outcomes	Unclear risk	Comment: does not state whether lost to follow‐up from intervention or control group; per‐protocol analysis, low attrition rate (92% completion rate)
Selective reporting (reporting bias)	Unclear risk	Comment: results appear to have been given for all outcomes but protocol not seen
Other bias	Unclear risk	Comment: none