Watson 2016.

Study characteristics
Methods	Review comparison(s) addressed by this study: 3, 4 Study design: RCT, parallel, number of centres NR Trial registry number: ANZCTR12613000008729 Total number of trial arms: 2 Year trial started: 2013 Sample size calculation: Yes Outcome(s) used for sample size calculation: Change in HbA1c Duration of run‐in period (weeks): NA What was the duration of the weight loss phase: 12 weeks What was the duration of the weight maintenance phase: 12 weeks Other notes about methods: NA
Participants	Country and setting: NR; likely Australia based on authors and funders  Eligibility criteria: Participants were aged 18 to 70 years and overweight or obese (defined as BMI ≥ 25 kg/m2) with type 2 diabetes (HbA1c 6.5 to 10.5%). Participants were excluded if they were diagnosed with or treated for any neurological or psychiatric condition (except for those on stable antidepressants for the past three months). Type 2 diabetes at baseline: Yes Impaired glucose tolerance at baseline: No Cardiovascular conditions/risk factors/events at baseline: No Gender: Mixed Total number randomised: 63 Total attrition in trial: 19 Treatment diet Participants randomised: 32 Participants withdrawn (voluntary): 9 Total attrition: 9 Control diet: Participants randomised: 31 Participants withdrawn (voluntary): 9 Total attrition: 10 Baseline data treatment diet: Randomised participants not included: 0/32 Age (years): mean (SD) 54 (8) Gender distribution (as reported): female 15/32 (47%), male 17/32 (53%) Weight (kg): mean (SD) 97.3 (17.1) BMI (kg/m2): mean (SD) 34.3 (5.4) DBP (mmHg): mean (SD) 78.4 (8.2) SBP (mmHg): mean (SD) 131.8 (13.2) HbA1c (%): mean (SD) 8.0 (1.3) LDL (mmol/L): mean (SD) 2.7 (0.9) HDL (mmol/L): mean (SD) 1.2 (0.3) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 4.7 (0.9) TG (mmol/L): mean (SD) 2.0 (1.2) Baseline data control diet: Randomised participants not included: 2/31 Age (years): mean (SD) 54 (8) Gender distribution (as reported): female 13/29 (45%), male 16/29 (55%) Weight (kg): mean (SD) 101.5 (16.6) BMI (kg/m2): mean (SD) 34.4 (4.7) DBP (mmHg): mean (SD) 79.0 (7.1) SBP (mmHg): mean (SD) 135.1 (8.3) HbA1c (%): mean (SD) 8.1 (1.5) LDL (mmol/L): mean (SD) 2.5 (0.6) HDL (mmol/L): mean (SD) 1.2 (0.3) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 4.5 (0.8) TG (mmol/L): mean (SD) 2.0 (1.0) Group differences at baseline: No Characteristic(s) with significant group difference and relevant statistic: NA Other notes about participants: NA
Interventions	Energy (E) comparison of treatment vs control diets: Similar energy prescription/approach to restrict energy intake in both diets Treatment diet: Name (as reported) and brief description: Higher‐protein diet. Planned macronutrient distribution of 32% protein, 33% carbohydrate and 30% fat with < 10% saturated. Physical activity 150 min/week. Moderate energy restriction of ~30% of the individual estimated energy requirement Treatment diet type (carbohydrate‐fat‐protein): Low‐balanced‐high Exercise component? Yes Recipients: Subjects were 47% female, aged mean (SD) 54 (8), BMI mean (SD) 34.3 (5.4) and weight 97.3 (17.1) kgs Why? The aim of this study was therefore to compare the effects of isocaloric HP and HC diets, combined with regular moderate intensity exercise, on glycaemic control and cardiometabolic risk factors in overweight and obese adults with T2DM initially following 12 weeks of active weight loss, and then to re‐evaluate the outcomes following 12 weeks of energy balance without the influence of weight change. By including an exercise component, we are able to determine the effects of the dietary patterns when administrated as part of a holistic lifestyle intervention as recommended in the management of T2DM. What (materials)? Core study foods corresponding to their assigned dietary pattern What (procedures)? HP diet being 32% of total energy as protein, 33% carbohydrate, and 30% total fat (< 10% as saturated fat). Participants received comprehensive dietary advice every 2 weeks. 30 mins of moderate intensity aerobic exercise, 5 times a week. Who provided? Dietitian How and where? Face‐to‐face session, location NR When and how much? Dietary intervention for 24 weeks; 12 weeks for weight loss and 12 weeks for maintenance. Participants attended clinic appointments at baseline and the end of each study phase (weeks 0, 12, and 24) for outcome assessments. Participants received comprehensive dietary advice from a qualified dietitian at baseline and every two weeks during the study. Daily semi‐quantitative food records were completed to guide dietary intake and to permit subsequent dietary analysis. Throughout the study, participants were asked to undertake a minimum of 30 min of moderate intensity aerobic exercise, five times per week. Strategies to improve or maintain fidelity; tailoring and modification: Daily semi‐quantitative food records were completed to guide dietary intake and to permit subsequent dietary analysis. Participants completed physical activity logs to monitor compliance. Extent of intervention fidelity: Total energy intake was similar between the groups for both intervention phases. Compared to the HC group, the HP group consumed significantly more protein and less carbohydrate and fibre (P < 0.05 for each nutrient) for each phase. As expected, the total fat intake in the HP diet was higher than the HC diet as a result of larger meat portions and the inclusion of reduced‐fat cheese and almonds, however both groups met the dietary recommendations for saturated fat intake (< 10% of energy intake). Concomitant interventions: 58% metformin; 19% insulin; 52% lipid‐lowering medication; 61% antihypertensive medication Control diet: Name (as reported) and brief description: Higher‐carbohydrate diet. Planned macronutrient distribution of 22% protein, 51% carbohydrate and 22% fat with < 10% saturated. Physical activity 150 min/week. Moderate energy restriction of ~30% of the individual estimated energy requirement Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐high Exercise component? Yes Recipients: Subjects were 45% female, aged mean (SD) 55 (8), BMI mean (SD) 34.4 (4.7) and weight 101.5 (16.6) kgs. Why? NR What (materials)? Core study foods corresponding to their assigned dietary pattern What (procedures)? HC diet was 22% protein, 51% carbohydrate, and 22% total fat (< 10% as saturated fat). Participants received comprehensive dietary advice every 2 weeks. 30 mins of moderate intensity aerobic exercise, 5 times a week Who provided? Dietitian How and where? Face‐to‐face session, location NR When and how much? Dietary intervention for 24 weeks; 12 weeks for weight loss and 12 weeks for maintenance. Participants attended clinic appointments at baseline and the end of each study phase (weeks 0, 12, and 24) for outcome assessments. Participants received comprehensive dietary advice from a qualified dietitian at baseline and every two weeks during the study. Daily semi‐quantitative food records were completed to guide dietary intake and to permit subsequent dietary analysis. Throughout the study, participants were asked to undertake a minimum of 30 min of moderate intensity aerobic exercise, five times per week. Strategies to improve or maintain fidelity; tailoring and modification: Daily semi‐quantitative food records were completed to guide dietary intake and to permit subsequent dietary analysis. Participants completed physical activity logs to monitor compliance. Extent of intervention fidelity: Total energy intake was similar between the groups for both intervention phases. Compared to the HC group, the HP group consumed significantly more protein and less carbohydrate and fibre (P < 0.05 for each nutrient) for each phase. As expected, the total fat intake in the HP diet was higher than the HC diet as a result of larger meat portions and the inclusion of reduced‐fat cheese and almonds, however both groups met the dietary recommendations for saturated fat intake (< 10% of energy intake). Concomitant interventions: 64 % meformin; 21% insulin; 64% lipid‐lowering medication; 43% antihypertensive medication
Outcomes	Change in body weight (kg) at 3 to < 12 months: Yes Change in body weight (kg) at ≥ 12 months: No Number of participants with 5% weight loss from baseline at 3 to < 12 months: Yes Number of participants with 5% weight loss from baseline at ≥ 12 months: No Change in BMI (kg/m2) at 3 to 12 months: Yes Change in BMI (kg/m2) at ≥ 12 months: No Number of participants with 5% BMI reduction from baseline at 3 to 12 months: No Number of participants with 5% BMI reduction from baseline at ≥ 12 months: No Change in DBP (mmHg) at ≥ 12 months: No Change in SBP (mmHg) at ≥ 12 months: No All‐cause mortality at ≥ 12 months: No Cardiovascular mortality at ≥ 12 months: No Non‐fatal myocardial infarction at ≥ 12 months: No Non‐fatal stroke at ≥ 12 months: No Diagnosis of type 2 diabetes mellitus at ≥ 12 months: No Change in HbA1c (%) at ≥ 12 months: No Change in LDL (mmol/L) at ≥ 12 months: No Change in HDL (mmol/L) at ≥ 12 months: No Change in non‐HDL (mmom/L) at ≥ 12 months: No Change in total cholesterol (TC) (mmol/L) at ≥ 12 months: No Change in triglycerides (or triacylglycerides) (TG) (mmol/L) at ≥ 12 months: No Participant‐reported adverse effects: Yes
Notes	Number and type of records(s): journal article Trial acronym/name: None Trial funded by: Pork Co‐operative Research Centre (Pork CRC) grant, an initiative of the Australian government Declaration of interest: "This study was funded by a grant from the Pork Co‐operative Research Centre (Pork CRC), an Australian Government funding initiative. NAW is supported by a post‐graduate research scholarship from the Pork CRC."