WINS 2006.

Study characteristics
Methods	RCT Women's Intervention Nutrition Study (WINS) Summary risk of bias: low
Participants	Women with localised resected breast cancer (USA) CVD risk: low Control: 1462 randomised, 1462 analysed Intervention: 975 randomised, 975 analysed Mean years in trial: overall 5.0 % men: 0 Age: control mean 58.5 (95% CI 43.6 to 73.4), intervention mean 58.6 (95% CI 44.4 to 72.8) (all postmenopausal) Ethnicity: 85% white, 5% black, 4% Hispanic, 5% Asian or Pacific Islander, < 1% American Indian or unknown (no outcome data based on ethnicity) Statins use allowed? Not stated (statins not mentioned in inclusion or exclusion criteria within trial protocol) % taking statins: Not reported
Interventions	Reduced fat intake vs usual diet Control aims: minimal nutritional counselling focused on nutritional adequacy Intervention aims: total fat 15 ‐ 20%E Control methods: 1 baseline dietetic session plus 3‐monthly sessions Intervention methods: 8 bi‐weekly individual dietetic sessions plus 3‐monthly contact and optional monthly group sessions, incorporating individual fat gram goals, social cognitive theory, self‐monitoring, goal‐setting, modelling, social support and relapse prevention and management Intervention was delivered face‐to‐face individually by trained dietitian Total fat intake, %E (at 1 year): int 20.3 (SD 8.1), cont 29.2 (SD 7.4) (mean difference ‐8.90, 95% CI ‐9.53 to ‐8.27) Total fat intake, %E (at 5 years): int 23.2 (SD 8.4) n = 380, cont 31.2 (SD 8.9) n = 648 (mean difference ‐8.00, 95% CI ‐9.09 to ‐6.91) significant reduction Saturated fat intake*, %E (at 1 year): int 6.4 (SD 0.14 [4.4]), cont 9.8 (SD 0.15 [5.7]) (mean difference ‐3.40, 95% CI ‐3.80 to ‐3.00 assuming reported SDs were actually SEs) significant reduction PUFA intake*, %E (at 1 year): int 4.5 (SD 0.09 (2.8)), cont 6.4 (SD 0.10 (3.8)) (mean difference ‐1.90, 95% CI ‐2.16 to ‐1.64) significant reduction PUFA n‐3 intake: not reported by study arm PUFA n‐6 intake: not reported by study arm MUFA intake*, %E (at 1 year): int 7.6 (SD 0.14 (4.4)), cont 11.5 (SD 0.16 (6.1)) (mean difference ‐3.90, 95% CI ‐4.32 to ‐3.48) significant reduction CHO intake, %E (at 6 months): int 60.8 (SD 19.6), cont 50.5 (SD 14.8) (mean difference 10.30, 95% CI 8.85 to 11.75) significant increase Protein intake, %E (at 6 months): int 19.1 (SD 5.2), cont 17.6 (SD 4.1) (mean difference 1.50, 95% CI 1.11 to 1.89) significant increase Trans fat intake: not reported Replacement for saturated fat: CHO and protein (based on dietary achievement) Style: dietary advice Setting: community *SDs appear incorrect, probably SEs?
Outcomes	Stated trial outcomes: dietary fat intake, total cholesterol, weight and waist measurement Data available on total mortality? yes Cardiovascular mortality? no Events available for combined cardiovascular events: none Secondary outcomes: cancer diagnoses Tertiary outcomes: weight, BMI, total cholesterol
Notes	Study duration 5 years Study aim was to reduce total fat to 15 ‐ 20%E SFA reduction achieved Total serum cholesterol, difference between intervention and control, mmol/L: ‐0.14 (95% CI ‐0.34 to 0.05), NO statistically significant reduction and reduction < 0.20 Trial dates: Recruitment 1994 to 2001 Funding: National Cancer Institute, Breast Cancer Research Foundation, American Institute for Cancer Research Declarations of Interest of primary researchers: none stated, all authors worked for academic or health institutions except that Njeri Karanja worked for Kaiser Permanente Center for Health Research, Bette Caan for Kaiser Permanente Medical Group, and Barbara L Winters for Campbell's Soup Company.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random stratified permuted block design, carried out at the statistical coordinating centre of WINS
Allocation concealment (selection bias)	Low risk	Random stratified permuted block design, carried out at the statistical coordinating centre of WINS
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not for dietary advice and participants
Blinding of outcome assessment (detection bias) CVD outcomes	Low risk	All outcomes assessed by the blinded outcome committee
Blinding of outcome assessment (detection bias) All‐cause mortality	Low risk	Outcome assessors blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	All assessed
Selective reporting (reporting bias)	Low risk	Not relevant for primary and secondary outcomes as all trialists were asked for data
Free of systematic difference in care?	High risk	Differences in attention ‐ more time for those in intervention group. See control and intervention methods in the Interventions section of the table of Characteristics of included studies
Stated aim to reduce SFA	High risk	Aim to reduce SFA not stated
Achieved SFA reduction	Low risk	SFA reduction achieved
Achieved TC reduction	High risk	No statistically significant TC fall
Other bias	Low risk	None noted

^{%E: percent of total energy intake
ATPII: Adult treatment panel II
BMI: body mass index (weight in kg/ height in m, squared)
BP: blood pressure
CABG: coronary artery bypass graft
CHD: coronary heart disease
CHO: carbohydrate
chol: cholesterol
CI: confidence interval
cont: control group
CVD: cardiovascular disease
DART: Diet And Reinfarction Trial
dBP: diastolic blood pressure
DVT: deep vein thrombosis
EPA: eicosapentaenoic acid
GPs: general practitioners
HDL: high density lipoprotein
HOMA: homeostatic model assessment
int: intervention group
ITT: Intention to treat analysis
LDL: low density lipoprotein
Lp(a): lipoprotein (a)
MI: myocardial infarction
MRC: Medical Research Council
MUFA: monounsaturated fat
P/S: polyunsaturated/saturated fat ratio
PCTA: percutaneous transluminal coronary angioplasty
PUFA: polyunsaturated fat
PVD: peripheral vascular disease
RCT: randomised controlled trial
sBP: systolic blood pressure
SD: standard deviation
SE: standard error
SFA: saturated fats
STARS: St Thomas' Atherosclerosis Regression Study
TC: total cholesterol
TG: triglyceride
vs: versus
WHI: Women's Health Initiative
WINS: Women's Intervention Nutrition Study}