Racette 1995.

Study characteristics
Methods	Review comparison(s) addressed by this study: 1, 2 Study design: RCT, parallel, number of centres NR Trial registry number: NR Total number of trial arms: 4 Year trial started: NR Sample size calculation: No Outcome(s) used for sample size calculation: NA Duration of run‐in period (weeks): 5 What was the duration of the weight loss phase: 12 weeks What was the duration of the weight maintenance phase: 6 weeks Other notes about methods: NA
Participants	Country and setting: USA, outpatient medical centre at a university in Chicago Eligibility criteria: Healthy, premenopausal women aged between 21 and 47 years, who are non‐smokers, were included. These women were included if they had a body weight between 140 and 180% of the midpoint for height (according to the 1959 Metropolitan Life Insurance Company table of desirable weights); had a body fat mass of more than 35% of total body weight; were weight‐stable; and had not engaged in formal exercise for more than three months prior to screening. Exclusion criteria NR Type 2 diabetes at baseline: No Impaired glucose tolerance at baseline: No Cardiovascular conditions/risk factors/events at baseline: No Gender: Female Total number randomised: 41 Total attrition in trial: 10 Treatment diet Participants randomised: NR Participants withdrawn (voluntary): NR Total attrition: NR Control diet: Participants randomised: NR Participants withdrawn (voluntary): NR Total attrition: NR Baseline data treatment diet: Randomised participants not included: NR (18/41 from total group randomised) Age (years): mean (SD) 41 (6) Gender distribution (as reported): NR Weight (kg): mean (SD) 94.0 (10.9) BMI (kg/m2): NR DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): NR HDL (mmol/L): NR Non‐HDL (mmol/L): NR TC (mmol/L): NR TG (mmol/L): NR Baseline data control diet: Randomised participants not included: NR (18/41 from total group randomised) Age (years): mean (SD) 37 (4) Gender distribution (as reported): NR Weight (kg): mean (SD) 92.7 (9.0) BMI (kg/m2): NR DBP (mmHg): NR SBP (mmHg): NR HbA1c (%): NR LDL (mmol/L): NR HDL (mmol/L): NR Non‐HDL (mmol/L): NR TC (mmol/L): NR TG (mmol/L): NR 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: Low‐carbohydrate diet prescribing 25% carbohydrate, 25% protein and 50% fat. Energy prescription of 75% of each participant's resting metabolic rate Treatment diet type (carbohydrate‐fat‐protein): Low‐high‐high Exercise component? No Recipients: N = 6 women only with mean (SD) age 41 (6) years, mean (SD) weight 94 (10.9) kg Why? Increasing carbohydrate when total energy intakes exceed 2.5 MJ/d is proposed to mitigate the adverse effects of a low‐energy diet by preventing the decreases in thyroid hormone activity and resting metabolism that are frequently observed. What (materials)? Participants were given food scales, measuring cups and spoons, and a notebook of meal plans and recipes to assist in their meal preparation. What (procedures)? The prescribed compositions of the weight reducing low‐carbohydrate diet was 25% carbohydrate, 25% protein, 50% fat. The reducing diets were designed to promote a weight loss of 1 kg/wk, with energy levels individually prescribed to approximate 75% of each subject’s measured RMR. All participants were required to attend weekly meetings, which included nutrition education classes, group discussions, collection of food diary booklets. Subjects were taught the exchange meal‐planning system and were instructed to consume a specific number of exchanges based on their prescribed energy level and diet composition. Subjects recorded all food and beverages they consumed, along with the corresponding exchanges, in daily food diaries. Booklets containing 7 d of daily diaries were collected weekly and analysed by the study dietitian for energy content and distribution by using the exchange system. Each subject received weekly feedback regarding both her dietary compliance and her accuracy in using the exchange system, and the dietitian met individually with subjects as necessary to improve these areas. Who provided? Dietitian How and where? Participants received weekly feedback and met individually with dietitian as required, location NR When and how much? Weekly meetings which included nutrition education classes, group discussions, collection of food diary booklets and weigh‐ins Strategies to improve or maintain fidelity; tailoring and modification: Subjects recorded all food and beverages they consumed, along with the corresponding exchanges, in daily food diaries. Booklets containing 7 d of daily diaries were collected weekly. Each subject received weekly feedback regarding both her dietary compliance and her accuracy in using the exchange system and the dietitian met individually with subjects as necessary to improve these areas. Extent of intervention fidelity: NR Concomitant interventions: NR Control diet: Name (as reported) and brief description: Low‐fat diet prescribing 60% carbohydrate, 25% protein and 15% fat. Energy prescription of 75% of each participant's resting metabolic rate Control diet type (carbohydrate‐fat‐protein): Balanced‐low‐high Exercise component? No Recipients: N = 7 women only with mean (SD) age 37 (4) years, mean (SD) weight 92.7 (9.0) kg Why? The maintenance diet was designed to maintain energy balance, with energy levels individually prescribed based on each subject’s RMR and an individualised activity factor of 1.6‐1.9. RMR values were calculated from the Harris‐Benedict formula during MI, whereas the measured RMR values were used during MII. Adjustments were made in the prescribed energy levels as necessary to minimise weight changes. The prescribed composition of the maintenance diet was 45% carbohydrate, 20% protein, and 35% fat. What (materials)? Participants were given food scales, measuring cups and spoons, and a notebook of meal plans and recipes to assist in their meal preparation. What (procedures)? The prescribed compositions of the weight‐reducing low‐fat diet was 60% carbohydrate, 25% protein, 15% fat. The reducing diets were designed to promote a weight loss of 1 kg/wk, with energy levels individually prescribed to approximate 75% of each subject’s measured RMR. All participants were required to attend weekly meetings, which included nutrition education classes, group discussions, collection of food diary booklets. Subjects were taught the exchange meal‐planning system and were instructed to consume a specific number of exchanges based on their prescribed energy level and diet composition. Subjects recorded all food and beverages they consumed, along with the corresponding exchanges, in daily food diaries. Booklets containing 7 d of daily diaries were collected weekly and analysed by the study dietitian for energy content and distribution by using the exchange system. Each subject received weekly feedback regarding both her dietary compliance and her accuracy in using the exchange system, and the dietitian met individually with subjects as necessary to improve these areas. Who provided? Dietitian How and where? Participants received weekly feedback and met individually with dietitian as required, location NR When and how much? Weekly meetings which included nutrition education classes, group discussions, collection of food diary booklets and weigh‐ins Strategies to improve or maintain fidelity; tailoring and modification: Subjects recorded all food and beverages they consumed, along with the corresponding exchanges, in daily food diaries. Booklets containing 7 d of daily diaries were collected weekly. Each subject received weekly feedback regarding both her dietary compliance and her accuracy in using the exchange system and the dietitian met individually with subjects as necessary to improve these areas. 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: No 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: No 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: No
Notes	Number and type of records(s): journal article Trial acronym/name: None Trial funded by: NIH (grant DK 30031), the Clinical Nutrition Research Unit (grant DK 26678), the Clinical Research Center (grant RR 00055) and Quaker Oats Co. Declaration of interest: NR Author contacted, but requested information not provided.