Calleja‐Fernández 2012.

Study characteristics
Methods	Review comparison(s) addressed by this study: 1 Study design: RCT, parallel, single‐centre (1) Trial registry number: NR Total number of trial arms: 2 Year trial started: NR Sample size calculation: Yes Outcome(s) used for sample size calculation: Difference in weight Duration of run‐in period (weeks): NA What was the duration of the weight loss phase: 1 year What was the duration of the weight maintenance phase: NA Other notes about methods: NA
Participants	Country and setting: Spain, outpatient university endocrinology and nutrition complex in León Eligibility criteria: Participants were overweight or obese (BMI between 28 and 35 kg/m2) and aged between 18 and 70 years. Participants were excluded if they participated in a weight loss treatment in the past six months; had a severe psychiatric illness; were pregnant or diabetic (defined as fasting plasma glucose > 126 mg/dL or > 200 mg/dL following an oral 75 g glucose tolerance test); had previous bariatric surgery or an eating disorder. Type 2 diabetes at baseline: No Impaired glucose tolerance at baseline: Unclear Cardiovascular conditions/risk factors/events at baseline: Unclear Gender: Mixed Total number randomised: 40 Total attrition in trial: 24 Treatment diet Participants randomised: 21 Participants withdrawn (voluntary): NR Total attrition: 13 Control diet: Participants randomised: 19 Participants withdrawn (voluntary): NR Total attrition: 11 Baseline data treatment diet: Randomised participants not included: None Age (years): mean (SD) 40.19 (13.16) Gender distribution (as reported): female 14/21 (66.7%), male 7/21 (33.3%) Weight (kg): mean (SD) 88.72 (13.43) BMI (kg/m2): mean (SD) 31.87 (2.71) DBP (mmHg): mean (SD) 79.62 (13.27) SBP (mmHg): mean (SD) 124.88 (18.08) HbA1c (%): NR LDL (mmol/L): mean (SD) 3.06 (0.69) HDL (mmol/L): mean (SD) 1.35 (0.47) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 5.26 (1.05) TG (mmol/L): mean (SD) 1.75 (1.15) Baseline data control diet: Randomised participants not included: None Age (years): mean (SD) 41.58 (14.50) Gender distribution (as reported): female 13/19 (68.4%), male 6/19 (31.6%) Weight (kg): mean (SD) 87.16 (10.38) BMI (kg/m2): mean (SD) 31.81 (2.04) DBP (mmHg): mean (SD) 77.24 (12.15) SBP (mmHg): mean (SD) 124.61 (17.20) HbA1c (%): NR LDL (mmol/L): mean (SD) 3.09 (0.73) HDL (mmol/L): mean (SD) 1.37 (0.38) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 5.25 (0.83) TG (mmol/L): mean (SD) 1.66 (0.68) Group differences at baseline: Yes Characteristic(s) with significant group difference and relevant statistic: characteristic 1: waist circumference (P = 0.026); intervention vs control 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: Diet A: 40% carbohydrate, 30% protein and 30% fat. The daily caloric intake for weight loss was calculated as the total caloric requirement minus 1000 kcal. Treatment diet type (carbohydrate‐fat‐protein): Low‐balanced‐high Exercise component? No Recipients: 40% carb ‐ participants were a mix of insulin sensitive and insulin resistant. Mean age 40.19 years, and mean BMI 31.87 kg/m2 Why? To evaluate the long‐term effects on weight loss and insulin resistance of the diet in obese people either with insulin resistance (IR) or without insulin resistance (IS) What (materials)? Written materials and daily food diary What (procedures)? Daily energy requirements were estimated using the resting metabolic rate calculated by the Harris‐Benedict equation, 10 and an activity factor of 1.5 was added in order to estimate the total caloric requirement. The daily caloric intake for weight loss was calculated as the total caloric requirement minus 1000 kcal. The subjects were free living and were asked to maintain their usual patterns of activity. Participants were prescribed a 40% carbohydrate, 30% protein and 30% fat diet. The dietitian was responsible for providing individual counselling and written material to the participants on the initial visit and then the patients were instructed to record their food intake in a daily food diary and to discuss it with the dietitian on each visit. Nutritional intake history, 24‐hr dietary recall and written food records were also assessed at all visits. Who provided? Dietitian How and where? face‐to‐face, location NR When and how much? "...visit every 2 weeks for 16 weeks at the beginning of the trial and on each 3 monthly visit for 1 year." Strategies to improve or maintain fidelity; tailoring and modification: A 72‐h dietary recall was performed at every visit. Same dietitian and personnel making assessments Extent of intervention fidelity: NR Concomitant interventions: NR Control diet: Name (as reported) and brief description: Diet B: 55% carbohydrate, 15% protein and 30% fat. The daily caloric intake for weight loss was calculated as the total caloric requirement minus 1000 kcal. Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐balanced Exercise component? No Recipients: 55% carb ‐ participants were a mix of insulin sensitive and insulin resistant. Mean age 41.58 years, and mean BMI 31.81 kg/m2 Why? To evaluate the long‐term effects on weight loss and insulin resistance of the diet in obese people either with insulin resistance (IR) or without insulin resistance (IS) What (materials)? Written materials and daily food diary What (procedures)? Daily energy requirements were estimated using the resting metabolic rate calculated by the Harris‐Benedict equation 10 and an activity factor of 1.5 was added in order to estimate the total caloric requirement. The daily caloric intake for weight loss was calculated as the total caloric requirement minus 1000 kcal. The subjects were free living and were asked to maintain their usual patterns of activity. Participants were prescribed a 55% carbohydrate, 15% protein and 30% fat diet.The dietitian was responsible for providing individual counselling and written material to the participants on the initial visit and then the patients were instructed to record their food intake in a daily food diary and to discuss it with the dietitian on each visit. Nutritional intake history, 24‐hr dietary recall and written food records were also assessed at all visits. Who provided? Dietitian How and where? Face‐to‐face, location NR When and how much? "...visit every 2 weeks for 16 weeks at the beginning of the trial and on each 3 monthly visit for 1 year." Strategies to improve or maintain fidelity; tailoring and modification: A 72‐h dietary recall was performed at every visit. Same dietitian and personnel making assessments Extent of intervention fidelity: NR Concomitant interventions: NR
Outcomes	Change in body weight (kg) at 3 to < 12 months: Yes Change in body weight (kg) at ≥ 12 months: Yes Number of participants with 5% weight loss from baseline at 3 to < 12 months: No 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: Yes 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: Yes Change in HDL (mmol/L) at ≥ 12 months: Yes Change in non‐HDL (mmom/L) at ≥ 12 months: No Change in total cholesterol (TC) (mmol/L) at ≥ 12 months: Yes Change in triglycerides (or triacylglycerides) (TG) (mmol/L) at ≥ 12 months: Yes Participant‐reported adverse effects: No
Notes	Number and type of records(s): journal article Trial acronym/name: None Trial funded by: None Declaration of interest: NR for primary reference. Ballesteros‐Pomar et al 2009: "No conflict of interests needs to be reported." Author contacted, but requested information not provided