Foraker 2014.

Study characteristics
Methods	Review comparison(s) addressed by this study: 1 Study design: RCT, parallel, single‐centre (1) Trial registry number: NCT01559194 Total number of trial arms: 2 Year trial started: 2005 Sample size calculation: Yes Outcome(s) used for sample size calculation: Difference in weight loss Duration of run‐in period (weeks): NA What was the duration of the weight loss phase: 52 weeks What was the duration of the weight maintenance phase: NA Other notes about methods: NA
Participants	Country and setting: USA, outpatient general clinical research centre in Columbus Eligibility criteria: Participants were overweight and obese premenopausal women aged 30 and above with BMI of 25 to 34 kg/m2; with no prior diagnosis of cancer (except nonmelanoma skin cancer) and medical clearance from their primary physician. Participants were excluded if they were pregnant or planning to become pregnant; were currently participating in a weight loss program; had medical conditions which preclude adherence or had uncontrolled existing medical conditions. Type 2 diabetes at baseline: Unclear; stratified with non‐T2DM since fasting insulin levels provided by author were mostly not indicative of diabetes. Impaired glucose tolerance at baseline: Unclear Cardiovascular conditions/risk factors/events at baseline: Unclear Gender: Female Total number randomised: 79 Total attrition in trial: 33 Treatment diet Participants randomised: 38 Participants withdrawn (voluntary): NR Total attrition: 19 Control diet: Participants randomised: 41 Participants withdrawn (voluntary): NR Total attrition: 14 Baseline data treatment diet: Randomised participants not included: None Age (years): mean (SD) 41.9 (5.4) Gender distribution (as reported): female 100%, male 0% Weight (kg): NR BMI (kg/m2): mean (SD) 30.1 (2.6) DBP (mmHg): mean (SD) 74.0 (8.7) SBP (mmHg): mean (SD) 121.3 (11.0) HbA1c (%): NR LDL (mmol/L): mean (SD) 3.09 (0.75) HDL (mmol/L): mean (SD) 1.42 (0.41) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 4.93 (0.87) TG (mmol/L): NR Baseline data control diet: Randomised participants not included: None Age (years): mean (SD) 40.9 (5.1) Gender distribution (as reported): female 100%, male 0% Weight (kg): NR BMI (kg/m2): mean (SD) 30.5 (2.9) DBP (mmHg): mean (SD) 75.1 (9.0) SBP (mmHg): mean (SD) 122.4 (14.7) HbA1c (%): NR LDL (mmol/L): mean (SD) 3.28 (0.84) HDL (mmol/L): mean (SD) 1.33 (0.29) Non‐HDL (mmol/L): NR TC (mmol/L): mean (SD) 5.12 (0.93) TG (mmol/L): NR Group differences at baseline: NR Characteristic(s) with significant group difference and relevant statistic: NA Other notes about participants: DBP and SBP baseline data not available for all randomised participants: intervention 2/38; control 1/41
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 comprising 40% carbohydrates, 30% protein and 30% fat with exercise (10,000 steps a day). Each participant provided with a calorie goal based on the Harris‐Benedict equation Treatment diet type (carbohydrate‐fat‐protein): Low‐balanced‐high Exercise component? Yes Recipients: Subjects were 100% female, aged mean (SD) 41.9 (5.4) years, BMI (SD) 30.1 (2.6). Why? We evaluated the effects of low‐fat and low‐carbohydrate weight‐loss diets on longitudinal measures of blood pressure and blood lipids among overweight or obese premenopausal women who were also advised to increase their level of physical activity. We hypothesised that we would observe favourable changes over time in blood pressure and blood lipids in both diet groups but that results would differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia. What (materials)? Digiwalker pedometer to count daily steps What (procedures)? LCD: 40% of total calories from carbohydrates, 30% from protein and 30% from fat plus physical activity. All participants were educated on colairic restriction and given personalised PA prescriptions. Each participant met with an RD at the university’s Clinic Research Centre (CRC) once per week for the first month of the study period, every three weeks during the second, third and fourth months of the study, and every 6 weeks for the remainder of the study, except weeks 34 and 52, which were clinic visits. All women received counselling regarding their respective calorie‐restricted diet, along with an individualised physical‐activity prescription to promote weight loss. If a participant couldn't make it, telephonic counselling sessions were arranged. Each participant was advised to walk 10,000 steps per day. Who provided? Dietitian How and where? Face‐to‐face individually or telephonically at the Clinical Research Centre When and how much? Weekly sessions for the first month, every 3 weeks for until month 4 then every 6 weeks Strategies to improve or maintain fidelity; tailoring and modification: If a participant was unable to attend a meeting with the RD, sessions were conducted by telephone. Adherence to the dietary interventions was assessed through 7‐day dietary recalls. Extent of intervention fidelity: Adherence to the dietary interventions was low for both arms (22% and 29% for LFD and LCD, respectively). Overall, participants were more compliant with the PA component of the intervention (66% and 61% among those randomised to the LFD and LCD arms, respectively). Concomitant interventions: NR Control diet: Name (as reported) and brief description: Low‐fat diet comprising 60% carbohydrates, 20% protein and 20% fat with exercise (10,000 steps a day). Each participant provided with a calorie goal based on the Harris‐Benedict equation Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐balanced Exercise component? Yes Recipients: Subjects were 100% female, aged mean (SD) 40.9 (5.1) years, BMI (SD) 30.5 (2.9) Why? We evaluated the effects of low‐fat and low‐carbohydrate weight‐loss diets on longitudinal measures of blood pressure and blood lipids among overweight or obese premenopausal women who were also advised to increase their level of physical activity. We hypothesised that we would observe favourable changes over time in blood pressure and blood lipids in both diet groups but that results would differ by level of adherence to the respective diet protocol and baseline presence of hypertension or hyperlipidemia. What (materials)? Digiwalker pedometer to count daily steps. What (procedures)? LFD: 20% of total calories from fat, 20% from protein and 60% from carbohydrates plus physical activity. All participants were educated on colairic restriction and given personalised PA prescriptions. Each participant met with an RD at the university’s Clinic Research Centre (CRC) once per week for the first month of the study period, every three weeks during the second, third and fourth months of the study, and every 6 weeks for the remainder of the study, except weeks 34 and 52, which were clinic visits. All women received counselling regarding their respective calorie‐restricted diet, along with an individualised physical‐activity prescription to promote weight loss. If a participant couldn't make it, telephonic counselling sessions were arranged. Each participant was advised to walk 10,000 steps per day. Who provided? Dietitian How and where? Face‐to‐face individually or telephonically at the Clinical Research Centre When and how much? Weekly sessions for the first month, every 3 weeks for until month 4 then every 6 weeks Strategies to improve or maintain fidelity; tailoring and modification: If a participant was unable to attend a meeting with the RD, sessions were conducted by telephone. Adherence to the dietary interventions was assessed through 7‐day dietary recalls. Extent of intervention fidelity: Adherence to the dietary interventions was low for both arms (22% and 29% for LFD and LCD, respectively). Overall, participants were more compliant with the PA component of the intervention (66% and 61% among those randomised to the LFD and LCD arms, respectively). 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: 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: Yes Change in SBP (mmHg) at ≥ 12 months: Yes 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: No Participant‐reported adverse effects: No
Notes	Number and type of records(s): journal article Trial acronym/name: LEAF Trial funded by: Breast Cancer Research Foundation and the National Center for Advancing Translational Sciences (grant 8UL1TR000090‐05) Declaration of interest: "No competing financial interests exist."