Hockaday 1978.

Study characteristics
Methods	Review comparison(s) addressed by this study: 3 Study design: RCT, parallel, single‐centre (1) Trial registry number: NR Total number of trial arms: 2 Year trial started: NR Sample size calculation: No Outcome(s) used for sample size calculation: NA Duration of run‐in period (weeks): NA What was the duration of the weight loss phase: 12 months What was the duration of the weight maintenance phase: NA Other notes about methods: NA
Participants	Country and setting: UK, outpatient hospital diabetic clinic in Oxford Eligibility criteria: Participants were newly‐diagnosed diabetics under 65 years who did not suffer from co‐existing major illness and did not need insulin therapy immediately. Participants were excluded if they had a history of, or current, endocrine disease, myocardial infarction or neurological deficit after a cerebrovascular accident; or were currently suffering from liver disease, however, those with a past history of liver disease were not excluded. 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Mixed Total number randomised: 93 Total attrition in trial: NR Treatment diet Participants randomised: 54 Participants withdrawn (voluntary): NR Total attrition: NR Control diet: Participants randomised: 39 Participants withdrawn (voluntary): NR Total attrition: NR Baseline data treatment diet: Randomised participants not included: None Age (years): mean (range) 53 (22 to 65) Gender distribution (as reported): female 22/54, male 32/54 Weight (kg): mean (range) 76.4 (51 to 99) 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): mean (SE) 6.5 (0.21) TG (mmol/L): mean (SE) 1.69 (0.12) Baseline data control diet: Randomised participants not included: None Age (years): mean (range) 50 (24 to 65) Gender distribution (as reported): female 19/39, male 20/39 Weight (kg): mean (range) 82.2 (56 to 114) 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): mean (SE) 6.2 (0.20) TG (mmol/L): mean (SE) 1.59 (0.12) Group differences at baseline: Yes Characteristic(s) with significant group difference and relevant statistic: characteristic 1: number of overweight participants (P < 0.02) 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 (LC) diet, 20% protein, 40% carbohydrate, 40% total fat (28% saturated and monounsaturated and 12% PUFA).  Energy prescription of 6300 kJ a day Treatment diet type (carbohydrate‐fat‐protein): Low‐high‐balanced Exercise component? No Recipients: Newly‐diagnosed diabetics, 40.7% female, aged mean 53 (range 22 to 65) years with weight mean 76.4 (range 51 to 99) kg. Having raised baseline levels of cholesterol, triglycerides, glucose and insulin Why? To investigate the effects of a low‐carb diet compared to low‐fat diet for development of cardiovascular risk factors. Low‐carbohydrate diets are normally prescribed to diabetic patients in the Western world. What (materials)? NR What (procedures)? Participants were instructed to consume a low‐carbohydrate diet, and were seen regularly to reinforce dietary advice. Dietary counselling at each visit Who provided? Dietitians met with participants to reinforce dietary advice at follow‐up visits How and where? Meeting with dieticians occurred face‐to‐face at the diabetic clinic from which participants were recruited. When and how much? The duration of the intervention was one year. Patients were seen by dietitians for the reinforcement of dietary advice after one month, and then every three months. Strategies to improve or maintain fidelity; tailoring and modification: Meetings at one month and at three‐month intervals thereafter to repeat dietary advice; weigh‐in at one month and one year Extent of intervention fidelity: Authors reported only that participants varied in their cooperation. Concomitant interventions: Participants did not require treatment with insulin or another oral hypoglycemic medication during the study. Control diet: Name (as reported) and brief description: Modified‐fat high‐carbohydrate (MF) diet, 20% protein, 54% carbohydrate, 26% total fat (10% saturated and monounsaturated and 16% PUFA). Energy prescription of 6300 kJ a day Control diet type (carbohydrate‐fat‐protein): Balanced‐balanced‐balanced Exercise component? No Recipients: Newly‐diagnosed diabetics, 48.7% female, aged mean 50 (range 24 to 65) years with weight mean 82.2 (range 56 to 114) kg. Having raised baseline levels of cholesterol, triglycerides, glucose and insulin Why? The Japanese, Trappists and Yemenite Jews consume diets high in carbohydrates; these populations tend to have lower serum lipids and lower prevalence of ischaemic heart disease ‐ both in diabetics as well as the general population. What (materials)? NR What (procedures)? Participants were instructed to consume a modified‐fat diet, and were seen regularly to reinforce dietary advice. Who provided? Dietitians met with participants to reinforce dietary advice at follow‐up visits. How and where? Meeting with dieticians occurred face‐to‐face at the diabetic clinic from which participants were recruited. When and how much? The duration of the intervention was one year. Patients were seen by dietitians for the reinforcement of dietary advice after one month, and then every three months. Strategies to improve or maintain fidelity; tailoring and modification: Meetings at one month and at three‐month intervals thereafter to repeat dietary advice; weigh‐in at one month and one year Extent of intervention fidelity: Authors reported only that participants varied in their cooperation. Concomitant interventions: Participants did not require treatment with insulin or another oral hypoglycemic medication during the study.
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: 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: 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: British Diabetic Association and the International Sugar Research Foundation Inc. Declaration of interest: NR