SUPPLEMENTARY MATERIAL

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1 SUPPLEMENTARY MATERIAL The effect of current dietary provided by frequent advice versus food delivery on weight loss and cardiovascular risk factors. A Randomized Clinical Trial. David JA Jenkins, Beatrice A. Boucher, Fredrick D. Ashbury, Margaret Sloan, Patrick Brown, Ahmed El-Sohemy, Anthony Hanley, Walter Willett, Melanie Paquette, Russell de Souza, Christopher Ireland, Natalie Kwan, Amy Jenkins, Sathish C. Pichika, Nancy Kreiger Supplementary Methods 1. Sample size calculation Supplementary Methods 2. Multiple imputation SAS code Supplementary Methods 3. ANOVA SAS code for participants as unit of analysis Supplementary Table 1. Baseline characteristics for the control and three treatment groups Supplementary Table 2. Dietary data at baseline and 6 months with 6 month changes (95% CI) and significance for the control and three treatment groups Supplementary Table 3. Treatment differences in dietary components as differences in change for the control and three treatment groups at 6 and 18 months Supplementary Table 4. Treatment differences in outcomes (differences in change) at 6 and 18 months for the control and three treatment groups. Data for individuals with household treated as random effect. Supplementary Table 5. Dietary data at 18 months for the control and three treatment groups Supplementary Table 6. Mean baseline values and changes in outcomes at 18 months for all participants Supplementary Table 7. Mean values and changes (95% CI) in outcomes at baseline and 18 months for the control and three treatment groups Supplementary Table 8. Treatment differences in outcomes (differences in change) at 6 and 18 months for the control and three treatment groups. Household treated as unit of analysis. Supplementary Table 9. Treatment differences in outcomes (differences in change) at 6 and 18 months for the control and three treatment groups. Data for individuals (BMI 25) with household treated as random effect. Supplementary Table 10. Serious adverse events Supplementary Figure 1. Changes in servings of fruit, vegetable and whole grains intake by treatment at 18 months Supplementary Figure month changes in study outcomes. Mean change and 95% confidence limit. 1

2 Supplementary Methods 1. Sample size calculation Sample size was based on the following assumptions: households are randomized to one of three main interventions(dietary advice, food delivery or advice plus food) or control sample size is first calculated based on a t-test for independent observations, and then inflated by a factor of 1 + (s-1)ρ, where s=2 (estimated number of individuals in each household), ρ=0.2 (estimated intra-class correlation to account for household clustering) the average weight of the control group will not decrease over the length of follow-up baseline mean weight in all groups is 78 kg, with a standard deviation of 8.5. Estimated sample size: Group Individual/Household Control 360 Dietary Advice 120 Food Delivery 120 Advice & Food 120 Least detectable alternatives between intervention and control group at α=0.05, 1-β=0.80 Measure Least detectable alternatives Mean body weight ± 1.54 kg Lipids (HDL,LDL) ± 0.06 mmol C-reactive protein ± 0.9 mg Homocysteine ± 0.65 mmol For the purpose of assessing the influence of advice to reduce soft drink consumption (to be reported separately), participants were randomized to one control and six treatments to accommodate a factorial design. However to achieve this objective the control remained undivided and instead a further cell was added that included 60 individuals/households representing a group who received advice on sugar sweetened beverage (SSB) avoidance. For the current study this group (n=60) was added to the control (n=360) making the final control number 420 individuals/households. For the purpose of the current analysis the factorial design was eliminated and the soft drink and no soft drink treatments were collapsed to form one control and three treatment groups (advice, food provision, and advice plus food provision). 2

3 Supplementary Methods 2. Multiple Imputation SAS Code Variable List visit = 1 for baseline, 2 for 6 months, 3 for 18 months hhid = Household id. Excluded hhids were taken from random digit dialing, and from non-randomized controls. random = Randomization with four categories: Control (CC), Advice (AD), Food delivery (FD), and food delivery plus advice (FA). ord_inc = income, ordinal ord_educ = education, ordinal age = continuous smoker = smoking status, binary gender = binary ht = height, continuous wt = weight (kg) base_ = prefix indicating baseline (visit 1) value for variable Imputation step for weight; proc mi nimpute = 5 seed = data= thds_mixed out= mi_thds_wt; where visit in (2,3) and hhid not in (10018,10082,10517,10805,11004,11993,14566,14863,16080,16210,16525,16994,17914,23208,23647, 23667,23559,22720,23625,23293,23408,23432,23236,23319,23473,23299,23653,23551,23498); monotone regpmm (wt = base_ord_inc base_ord_educ2 base_age base_smoker gender base_ht visit base_wt); var base_ord_inc base_ord_educ base_age base_smoker gender base_ht visit base_wt wt; ods exclude all; quit; 3

4 Supplementary Methods 3. ANCOVA SAS code for participants as unit of analysis Analysis 6 months; proc mixed data = mi_thds_wt; where visit in (2) and hhid not in (10018,10082,10517,10805,11004,11993,14566,14863,16080,16210,16525,16994,17914,23208,23647, 23667,23559,22720,23625,23293,23408,23432,23236,23319,23473,23299,23653,23551,23498); by _imputation_; class random hhid; model wt = random base_wt /ddfm=kr; random hhid; Hierarchical model term. Treats each household unit as a separate block; estimate "AD_CC" random ; estimate "AD_FA" random ; estimate "AD_FD" random ; estimate "CC_FA" random ; estimate "CC_FD" random ; estimate "FA_FD" random ; ods exclude all; ods output estimates = est; run; proc mianalyze data=est edf=914; title "Weight Advice vs Control"; where label = "AD_CC"; modeleffects Estimate; stderr stderr; ods select ParameterEstimates; run; First comparison shown. Control versus advice. ; 4

5 Supplementary Table 1. Baseline characteristics for the control and three treatment groups Control Advice Only Food Only Food and Advice N=486 N=145 N=148 N=140 P-value Age (years) 44.9 ( ) 46.2 ( ) 44.9 ( ) 42.4 ( ) Sex Female 386 (79.4) 110 (75.9) 107 (72.3) 107 (76.4) Male 100 (20.6) 35 (24.1) 41 (27.7) 33 (23.6) Non-smoker 447 (92) 132 (91) 136 (91.9) 132 (94.3) Smoker 39 (8) 13 (9) 12 (8.1) 8 (5.7) Whites 290 (67.6) 86 (69.4) 90 (67.2) 85 (66.4) Non-whites 139 (32.4) 38 (30.7) 44 (32.8) 43 (33.6) Household Income Less than 20 K 67 (14.1) 13 (9.4) 11 (7.8) 18 (13.2) K 82 (17.3) 25 (18) 22 (15.5) 22 (16.2) K 172 (36.2) 50 (36) 51 (35.9) 55 (40.4) K 88 (18.5) 38 (27.3) 26 (18.3) 28 (20.6) 120 K + 66 (13.9) 13 (9.4) 32 (22.5) 13 (9.6) Education High school / Elementary 54 (11.2) 17 (11.8) 16 (10.8) 14 (10.1) Some college / Undergraduate 121 (25) 35 (24.3) 23 (15.5) 34 (24.5) College / University degree 202 (41.7) 63 (43.8) 74 (50) 56 (40.3) Graduate degree 107 (22.1) 29 (20.1) 35 (23.7) 35 (25.2) Weight (kg) 88 ( ) 86.2 ( ) 89.2 ( ) 89.6 ( ) BMI (kg/m2) 32.5 (32-33) 31.7 ( ) 32.6 ( ) 32.7 ( ) Waist (cm) ( ) ( ) ( ) ( ) Glucose (mmol/l) 4.81 ( ) 4.87 ( ) 4.8 ( ) 4.81 ( ) Total Cholesterol (mmol/l) 5.09 (5-5.17) 5.17 ( ) 5 ( ) 4.89 ( ) LDL-C (mmol/l) 3.27 ( ) 3.3 ( ) 3.17 ( ) 3.07 ( ) HDL-C (mmol/l) 1.27 ( ) 1.32 ( ) 1.27 ( ) 1.3 ( ) Triglycerides (mmol/l) 1.23 ( ) 1.2 ( ) 1.21 ( ) 1.14 ( ) Total cholesterol/hdl 4.2 ( ) 4.16 ( ) 4.19 ( ) 3.99 ( ) Non-HDL cholesterol (mmol/l 3.81 ( ) 3.85 ( ) 3.73 ( ) 3.59 ( ) Systolic blood pressure ( ) ( ) ( ) 114 ( ) Diastolic blood pressure 73.3 ( ) 72.2 ( ) 72.9 ( ) 72.7 ( ) Mean arterial pressure 87.1 ( ) 86.4 ( ) 86.8 ( ) 86.5 ( ) year CHD risk (%) 3.55 ( ) 4.03 ( ) 3.82 ( ) 2.94 ( ) Blood pressure medication 42 (8.7) 13 (9) 15 (10.1) 8 (5.7) Cholesterol medication 28 (5.8) 11 (7.6) 11 (7.4) 7 (5) Data are expressed as means (95% CI) or n (%). To convert the values to milligrams per deciliter, divide cholesterol by , triglycerides by and glucose by P values taken from Fisher's exact test for categorical variables (sex, smoking status, ethnicity, medications) Mantel-Haenszel χ 2 for ordinal variables (income, education), and analysis of variance for continous variables (all others). Missing data (Ethnicity n=104, Income n=14, Education n=4, Blood pressure medication n=3, Cholesterol medication n=3). 5

6 Supplementary Table 2. Dietary data at baseline and 6 months with 6 month changes (95% CI) and significance for the control and three treatment groups Baseline (n=484) Control 6 Months (n=317) 6 Month (n=317) Pr > t Baseline (n=148) Food 6 Months (n=131) 6 Month (n=131) Pr > t Energy (kcal) 2067 (1996, 2139) 1874 (1792, 1956) -157 (-232, -82) < (1979, 2255) 2163 (2011, 2316) 31 (-111, 173) Available CHO (% kcal) 45.2 (44.5, 46) 44.9 (44.1, 45.8) -0.6 (-1.4, 0.1) (42.9, 45.3) 44.3 (43.1, 45.5) 0.1 (-1.1, 1.3) Sugar (% kcal) 24 (23.4, 24.7) 23.9 (23.1, 24.7) -0.5 (-1.3, 0.2) (21.7, 24) 23.7 (22.5, 24.8) 0.8 (-0.4, 1.9) Starch (% kcal) 21.2 (20.7, 21.7) 21.1 (20.4, 21.7) -0.1 (-0.8, 0.5) (20.3, 22.2) 20.7 (19.8, 21.5) -0.6 (-1.7, 0.4) Fiber (g/1000 kcal) 12.6 (12.2, 12.9) 14.4 (13.9, 14.9) 1.6 (1.1, 2) < (11.5, 12.9) 17 (16, 17.9) 4.9 (3.9, 5.8) <.0001 Protein (% kcal) 17.1 (16.8, 17.4) 18.1 (17.7, 18.5) 0.9 (0.5, 1.3) < (16.5, 17.6) 17.6 (17.1, 18.2) 0.4 (-0.2, 1) Animal Protein (% kcal) 10.9 (10.5, 11.2) 11.6 (11.1, 12.1) 0.6 (0.2, 1) (10.4, 11.6) 10.6 (9.9, 11.2) -0.5 (-1.2, 0.1) Vegetable Protein (% kcal) 6.2 (6, 6.3) 6.5 (6.3, 6.7) 0.3 (0.1, 0.5) (5.9, 6.4) 7.1 (6.7, 7.4) 0.9 (0.6, 1.3) <.0001 Fat (% kcal) 32.7 (32.1, 33.3) 31.4 (30.7, 32.2) -0.6 (-1.3, 0.2) (32.7, 34.8) 32.7 (31.6, 33.8) -0.9 (-1.9, 0.2) Saturated Fat (% kcal) 10.1 (9.8, 10.3) 9.5 (9.2, 9.7) -0.4 (-0.6, -0.1) (10, 10.8) 9.4 (9, 9.8) -1 (-1.5, -0.6) <.0001 Monounsaturated Fat (% kcal) 13.5 (13.2, 13.9) 13 (12.6, 13.4) -0.2 (-0.7, 0.3) (13.2, 14.4) 13.7 (13.1, 14.4) 0.1 (-0.5, 0.7) Polyunsaturated Fat (% kcal) 6.2 (6, 6.4) 6.1 (5.9, 6.4) 0 (-0.2, 0.2) (6.2, 6.9) 6.6 (6.3, 7) 0.2 (-0.1, 0.5) Cholesterol (g/1000 kcal) 123 (119, 127) 128 (122, 134) 6 (0, 11) (118, 131) 120 (113, 128) -6 (-14, 2) Alcohol (% kcal) 2.4 (2.1, 2.8) 2.5 (2, 3) 0 (-0.4, 0.4) (2, 3) 2.2 (1.7, 2.7) -0.3 (-0.6, 0) Fruit servings 1.5 (1.4, 1.6) 1.8 (1.6, 2) 0.3 (0.1, 0.4) < (1.1, 1.5) 2.2 (1.9, 2.4) 0.8 (0.6, 1) <.0001 Vegetable servings 1.5 (1.3, 1.6) 1.9 (1.7, 2) 0.4 (0.3, 0.6) < (1.3, 1.7) 2.2 (2, 2.5) 0.7 (0.5, 1) <.0001 Whole grain servings 1.5 (1.4, 1.6) 1.5 (1.4, 1.7) 0 (-0.1, 0.2) (1.4, 1.7) 2.2 (2, 2.5) 0.7 (0.5, 0.9) <.0001 Low fat dairy servings 0.6 (0.6, 0.7) 0.7 (0.6, 0.8) 0 (0, 0.1) (0.5, 0.8) 0.7 (0.5, 0.8) 0 (-0.1, 0.2) Nuts (g) 10.7 (9, 12.3) 10.1 (8.3, 11.8) -0.1 (-2.1, 1.9) (8.8, 14.2) 16.7 (13.2, 20.2) 5.2 (2, 8.4) Soy protein (g) 1.9 (1.4, 2.5) 1.7 (1.3, 2.1) -0.3 (-0.9, 0.4) (1, 2.3) 3.3 (2.5, 4) 1.6 (0.8, 2.5) <.001 Viscous Fiber (g) 0.4 (0.3, 0.4) 0.5 (0.4, 0.6) 0.1 (0, 0.2) (0.3, 0.7) 1.5 (1.1, 1.8) 1 (0.6, 1.3) <.0001 Advice Food and Advice Baseline (n=145) 6 Months (n=87) 6 Month (n=87) Pr > t Baseline (n=138) 6 Months (n=123) 6 Month (n=121) Pr > t Energy (kcal) 2128 (1955, 2301) 1973 (1822, 2123) -154 (-311, 3) (1874, 2264) 2089 (1928, 2251) -32 (-228, 165) Available CHO (% kcal) 45.4 (44.3, 46.5) 45.4 (44, 46.8) -0.5 (-1.9, 0.9) (41.7, 44.6) 43.3 (42.1, 44.5) 0.7 (-0.7, 2) Sugar (% kcal) 24.1 (23, 25.3) 24.6 (23.3, 26) -0.5 (-2, 0.9) (21.2, 23.7) 21.3 (20.2, 22.4) -0.7 (-1.9, 0.4) Starch (% kcal) 21.3 (20.3, 22.2) 20.8 (19.8, 21.8) 0 (-1, 1) (19.7, 21.7) 22 (21.2, 22.8) 1.4 (0.4, 2.4) Fiber (g/1000 kcal) 12.3 (11.5, 13) 15.1 (14.1, 16) 2.7 (1.7, 3.6) < (11.6, 13.1) 18.3 (17.2, 19.3) 5.7 (4.7, 6.8) <.0001 Protein (% kcal) 16.5 (16, 17.1) 17.9 (17.2, 18.6) 1.2 (0.5, 1.9) (17.7, 19.4) 18.4 (17.8, 19.1) -0.3 (-1.2, 0.5) Animal Protein (% kcal) 10.6 (10, 11.2) 11.3 (10.5, 12.1) 0.6 (-0.1, 1.2) (11.6, 13.5) 10.8 (10, 11.5) -1.9 (-2.9, -0.9) <.001 Vegetable Protein (% kcal) 6 (5.7, 6.3) 6.6 (6.2, 7) 0.6 (0.3, 0.9) (5.7, 6.3) 7.7 (7.3, 8) 1.6 (1.2, 1.9) <.0001 Fat (% kcal) 32.7 (31.6, 33.8) 31.2 (30, 32.4) -0.9 (-2.1, 0.4) (32.1, 34.4) 31.9 (30.8, 33) -1.5 (-2.6, -0.4) Saturated Fat (% kcal) 10.3 (9.9, 10.8) 9.3 (8.8, 9.8) -1 (-1.5, -0.4) (9.6, 10.5) 8.5 (8.1, 8.9) -1.6 (-2, -1.2) <.0001 Monounsaturated Fat (% kcal) 13.5 (12.8, 14.1) 13 (12.3, 13.8) 0 (-0.8, 0.7) (13.3, 14.6) 13.8 (13.1, 14.5) -0.3 (-1, 0.4) Polyunsaturated Fat (% kcal) 6 (5.8, 6.3) 6.1 (5.7, 6.5) 0.2 (-0.1, 0.6) (5.9, 6.6) 6.7 (6.3, 7.1) 0.5 (0.1, 0.9) Cholesterol (g/1000 kcal) 122 (114, 131) 122 (111, 133) -1 (-12, 10) (129, 151) 122 (112, 132) -20 (-31, -9) Alcohol (% kcal) 2.8 (2.1, 3.5) 2.3 (1.6, 3) -0.4 (-1, 0.2) (1.7, 3) 2.8 (1.9, 3.8) 0.3 (-0.2, 0.8) Fruit servings 1.4 (1.2, 1.6) 2.1 (1.8, 2.4) 0.6 (0.3, 0.9) (1.2, 1.7) 2.7 (2.4, 2.9) 1.1 (0.8, 1.4) <.0001 Vegetable servings 1.3 (1.1, 1.5) 2.1 (1.9, 2.4) 0.8 (0.5, 1.1) < (1.3, 1.8) 2.9 (2.6, 3.1) 1.3 (1, 1.5) <.0001 Whole grain servings 1.5 (1.4, 1.7) 1.9 (1.7, 2.2) 0.4 (0.1, 0.6) (1.3, 1.6) 2.5 (2.2, 2.7) 1 (0.7, 1.2) <.0001 Low fat dairy servings 0.6 (0.5, 0.7) 0.9 (0.7, 1.1) 0.2 (0.1, 0.4) (0.5, 0.7) 0.6 (0.5, 0.8) 0 (-0.1, 0.2) Nuts (g) 11 (7.6, 14.4) 10.7 (7.6, 13.7) 1.7 (-2, 5.4) (5.8, 10.3) 14.7 (11.8, 17.6) 6.5 (3.3, 9.7) <.001 Soy protein (g) 1.6 (1, 2.1) 2.2 (1.4, 3) 0.3 (-0.2, 0.9) (0.8, 2) 3.8 (3, 4.7) 2.3 (1.5, 3.2) <.0001 Viscous Fiber (g) 0.3 (0.2, 0.5) 0.7 (0.4, 0.9) 0.4 (0.2, 0.5) < (0.1, 0.4) 1.6 (1.3, 1.9) 1.4 (1, 1.8) <.0001 Data are means (95% CI). 4 people were missing dietary data at baseline, and 27 people at 6 months. Whole grain servings calculated as grams of whole grains from FFQ divided by 30 One low fat dairy serving = 1 cup low fat milk or yogurt, 1.5oz low fat cheese, or ½ cup cottage cheese 6

7 Supplementary Table 3. Treatment differences in dietary components as differences in change for the control and three treatment groups at 6 and 18 months 0 to 6 95% CI Adjp 0 to 18 95% CI Adjp 6 to 18 95% CI Adjp Group month month month Energy (kcal) A C A FA A F C FA C F FA F Available CHO (% kcal) A C A FA A F C FA C F FA F Sugar (% kcal) A C A FA A F C FA C F FA F Starch (% kcal) A C A FA A F C FA C F FA F Fiber (g/1000 kcal) A C A FA < A F C FA < <.001 C F < FA F Protein (% kcal) A C Animal Protein (% kcal) Vegetable Protein (% kcal) A FA A F C FA C F FA F A C A FA A F C FA < C F FA F A C A FA < A F C FA < C F FA F

8 Supplementary Table 3. Treatment differences in dietary components as differences in change for the control and three treatment groups at 6 and 18 months 0 to 6 95% CI Adjp 0 to 18 95% CI Adjp 6 to 18 95% CI Adjp Group month month month Fat (% kcal) A C A FA A F C FA C F FA F Saturated Fat (% kcal) A C Monounsaturated Fat (% kcal) Polyunsaturated Fat (% kcal) Cholesterol (g/1000 kcal) A FA A F C FA < C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F Alcohol (% kcal) A C A FA A F C FA C F FA F Fruit servings A C A FA A F C FA < C F FA F Vegetable servings A C A FA A F C FA < C F FA F

9 Supplementary Table 3. Treatment differences in dietary components as differences in change for the control and three treatment groups at 6 and 18 months 0 to 6 95% CI Adjp 0 to 18 95% CI Adjp 6 to 18 95% CI Adjp Group month month month Whole grain servings A C A FA A F C FA < C F < FA F Low fat dairy servings A C A FA A F C FA C F FA F Nuts (g) A C A FA A F C FA C F FA F Soy protein (g) A C A FA A F C FA < C F < FA F Viscous Fiber (g) A C A FA < A F C FA < < C F < FA F Differences taken from method of least squares means, with end value as outcome, and starting value (baseline or 6 months) as a covariate in the ANCOVA model. A Tukey adjustment was applied to adjust for multiple pairwise comparisons. 9

10 Supplementary Table 4. Treatment differences in outcomes (differences in change) at 6 and 18 months for the control and three treatment groups. Data for individuals with household treated as random effect. 0 to 6 Months 0 to 18 Months 6 to 18 Months Treatment Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Weight (kg) A C A FA BMI (kg/m2) Waist (cm) Glucose (mmol/l) Total Cholesterol (mmol/l) LDL-c (mmol/l) HDL-c (mmol/l) A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F To convert the values to milligrams per deciliter, divide cholesterol by , triglycerides by and glucose by Treatments: C, control; A, advice; F, food delivery; FA, and food delivery and advice 10

11 Supplementary Table 4. Treatment differences in outcomes (differences in change) at 6 and 18 months for the control and three treatment groups. Data for individuals with household treated as random effect. 0 to 6 Months 0 to 18 Months 6 to 18 Months Treatment Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Triglycerides (mmol/l) A C A FA Total Cholesterol/HDL-c Non-HDL-c (mmol/l) Systolic blood pressure Diastolic blood pressure Mean Arterial Pressure 10 year CHD risk (%) A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F To convert the values to milligrams per deciliter, divide cholesterol by , triglycerides by and glucose by Treatments: C, control; A, advice; F, food delivery; FA, and food delivery and advice 11

12 Supplementary Table 5. Dietary data at 18 months for the control and three treatment groups Baseline (n=484) Control 18 month (n=278) Pr > t 6 to 18 month (n=266) Pr > t Baseline (n=148) Food Only 18 month (n=118) Pr > t 6 to 18 month (n=110) 18 months (n=278) 18 months (n=118) Energy (kcal) 2067 (1996, 2139) 2011 (1923, 2099) -23 (-105, 59) (48, 187) (1979, 2255) 2084 (1957, 2211) -35 (-178, 108) (-223, 4) Available CHO (% kcal) 45.2 (44.5, 46) 44.7 (43.7, 45.6) -0.7 (-1.5, 0.2) (-0.8, 0.9) (42.9, 45.3) 44.2 (42.9, 45.5) 0.1 (-1.3, 1.6) (-1.2, 1.5) Sugar (% kcal) 24 (23.4, 24.7) 23.4 (22.6, 24.3) -0.7 (-1.6, 0.1) (-1.1, 0.5) (21.7, 24) 23.3 (22, 24.6) 0.5 (-0.9, 1.8) (-1.1, 1.3) Starch (% kcal) 21.2 (20.7, 21.7) 21.3 (20.6, 22) 0.1 (-0.6, 0.8) (-0.3, 0.9) (20.3, 22.2) 20.8 (19.9, 21.8) -0.4 (-1.3, 0.6) (-0.9, 1) Fiber (g/1000 kcal) 12.6 (12.2, 12.9) 14.5 (14, 15) 1.7 (1.2, 2.1) < (-0.2, 0.6) (11.5, 12.9) 14.7 (13.8, 15.6) 2.7 (1.9, 3.6) < (-3.1, -1.3) <.0001 Protein (% kcal) 17.1 (16.8, 17.4) 18 (17.6, 18.5) 1 (0.5, 1.4) < (-0.5, 0.4) (16.5, 17.6) 17.4 (16.9, 17.9) 0.2 (-0.4, 0.9) (-0.8, 0.4) Animal Protein (% kcal) 10.9 (10.5, 11.2) 11.6 (11, 12.1) 0.7 (0.2, 1.2) (-0.5, 0.4) (10.4, 11.6) 10.9 (10.3, 11.5) -0.2 (-1, 0.5) (-0.4, 1.1) Vegetable Protein (% kcal) 6.2 (6, 6.3) 6.5 (6.3, 6.7) 0.3 (0.1, 0.4) (-0.2, 0.2) (5.9, 6.4) 6.5 (6.2, 6.9) 0.5 (0.1, 0.9) (-0.9, -0.1) Fat (% kcal) 32.7 (32.1, 33.3) 31.8 (31, 32.6) -0.4 (-1.2, 0.4) (-0.6, 0.9) (32.7, 34.8) 32.9 (31.6, 34.2) -0.8 (-2.2, 0.6) (-1.2, 1.3) Saturated Fat (% kcal) 10.1 (9.8, 10.3) 9.5 (9.3, 9.8) -0.3 (-0.6, -0.1) (-0.2, 0.3) (10, 10.8) 9.6 (9.2, 10) -0.7 (-1.2, -0.2) (-0.1, 0.7) Monounsaturated Fat (% kcal) 13.5 (13.2, 13.9) 13.1 (12.7, 13.6) -0.3 (-0.8, 0.2) (-0.5, 0.4) (13.2, 14.4) 13.9 (13.1, 14.7) 0 (-0.8, 0.9) (-0.7, 0.8) Polyunsaturated Fat (% kcal) 6.2 (6, 6.4) 6.4 (6.1, 6.6) 0.2 (0, 0.5) (-0.1, 0.4) (6.2, 6.9) 6.6 (6.2, 7) 0.1 (-0.3, 0.5) (-0.6, 0.3) Cholesterol (g/1000 kcal) 123 (119, 127) 126 (121, 132) 5 (-1, 10) (-5, 6) (118, 131) 124 (117, 132) -3 (-12, 5) (-4, 14) Alcohol (% kcal) 2.4 (2.1, 2.8) 2.5 (2, 2.9) -0.2 (-0.5, 0.1) (-0.4, 0.2) (2, 3) 2.6 (2, 3.2) 0.1 (-0.3, 0.5) (-0.1, 0.7) Fruit servings 1.5 (1.4, 1.6) 1.9 (1.7, 2) 0.4 (0.2, 0.5) < (-0.1, 0.2) (1.1, 1.5) 1.9 (1.6, 2.2) 0.6 (0.3, 0.8) < (-0.6, 0) Vegetable servings 1.5 (1.3, 1.6) 1.8 (1.7, 2) 0.3 (0.2, 0.5) < (-0.3, 0.1) (1.3, 1.7) 2.1 (1.8, 2.3) 0.6 (0.3, 0.8) < (-0.4, 0.1) Whole grain servings 1.5 (1.4, 1.6) 1.7 (1.6, 1.9) 0.2 (0, 0.3) (0, 0.3) (1.4, 1.7) 1.7 (1.5, 1.9) 0.2 (0, 0.4) (-0.9, -0.3) <.0001 Low fat dairy servings 0.6 (0.6, 0.7) 0.7 (0.6, 0.8) 0 (-0.1, 0.1) (-0.1, 0.1) (0.5, 0.8) 0.7 (0.6, 0.9) 0.1 (-0.1, 0.3) (-0.1, 0.3) Nuts (g) 10.7 (9, 12.3) 14.6 (12, 17.2) 3.6 (1.3, 5.9) (1.5, 6) (8.8, 14.2) 16.5 (11.1, 21.9) 4.7 (0.2, 9.3) (-5.9, 3.7) Soy protein (g) 1.9 (1.4, 2.5) 1.6 (1.1, 2) -0.4 (-1, 0.3) (-0.5, 0.3) (1, 2.3) 2 (1, 3.1) 0.6 (-0.5, 1.7) (-2.7, -0.1) Viscous Fiber (g) 0.4 (0.3, 0.4) 0.4 (0.3, 0.5) 0 (-0.1, 0.1) (-0.2, 0.1) (0.3, 0.7) 0.7 (0.4, 1) 0.2 (-0.1, 0.4) (-1.2, -0.4) <.001 Advice Only Food and Advice Baseline (n=145) 18 months (n=75) 18 month Pr > t 6 to 18 month Pr > t Baseline (n=138) 18 months (n=103) 18 month Pr > t 6 to 18 month Pr > t (n=75) (n=73) (n=101) (n=102) Energy (kcal) 2128 (1955, 2301) 1998 (1814, 2182) -120 (-313, 72) (-84, 220) (1874, 2264) 1984 (1837, 2131) -191 (-406, 25) (-218, 21) Available CHO (% kcal) 45.4 (44.3, 46.5) 42.8 (41.1, 44.5) -2.7 (-4.2, -1.2) (-4.1, -0.8) (41.7, 44.6) 43 (41.5, 44.6) 0 (-1.7, 1.8) (-1.5, 0.8) Sugar (% kcal) 24.1 (23, 25.3) 22.8 (21.5, 24.2) -1.8 (-3.2, -0.4) (-3.3, -0.5) (21.2, 23.7) 21.5 (20.1, 22.9) -0.6 (-2.2, 1) (-0.9, 1.2) Starch (% kcal) 21.3 (20.3, 22.2) 19.9 (18.7, 21.2) -0.9 (-2.1, 0.3) (-1.5, 0.5) (19.7, 21.7) 21.6 (20.6, 22.5) 0.6 (-0.4, 1.7) (-1.6, 0.6) Fiber (g/1000 kcal) 12.3 (11.5, 13) 14.5 (13.4, 15.6) 1.9 (1, 2.7) < (-1.6, 0.4) (11.6, 13.1) 15.3 (14.4, 16.2) 2.8 (1.9, 3.7) < (-3.9, -2.2) <.0001 Protein (% kcal) 16.5 (16, 17.1) 17.9 (17.1, 18.7) 1.3 (0.4, 2.2) (-0.7, 1) (17.7, 19.4) 18.2 (17.5, 18.8) 0.2 (-0.4, 0.8) (-0.7, 0.5) Animal Protein (% kcal) 10.6 (10, 11.2) 11.4 (10.5, 12.4) 0.9 (0, 1.8) (-0.7, 1.2) (11.6, 13.5) 11.4 (10.7, 12.1) -0.4 (-1.1, 0.3) (0.3, 1.5) Vegetable Protein (% kcal) 6 (5.7, 6.3) 6.5 (6.1, 6.9) 0.4 (0.1, 0.8) (-0.5, 0.3) (5.7, 6.3) 6.8 (6.4, 7.1) 0.6 (0.3, 0.9) < (-1.3, -0.7) <.0001 Fat (% kcal) 32.7 (31.6, 33.8) 33.8 (32.3, 35.3) 1.3 (0.1, 2.5) (1, 3.8) (32.1, 34.4) 32.7 (31.2, 34.1) -0.8 (-2.3, 0.7) (-0.3, 2.3) Saturated Fat (% kcal) 10.3 (9.9, 10.8) 10.1 (9.5, 10.7) -0.4 (-0.9, 0.2) (0.4, 1.3) (9.6, 10.5) 9.2 (8.8, 9.6) -0.9 (-1.3, -0.4) (0.4, 1.1) <.0001 Monounsaturated Fat (% kcal) 13.5 (12.8, 14.1) 14.2 (13.4, 15.1) 1 (0.2, 1.7) (0.1, 1.8) (13.3, 14.6) 14 (13.1, 15) -0.2 (-1.1, 0.7) (-0.4, 1.4) Polyunsaturated Fat (% kcal) 6 (5.8, 6.3) 6.5 (6.1, 6.8) 0.5 (0.1, 0.9) (0, 0.7) (5.9, 6.6) 6.5 (6.1, 7) 0.3 (-0.2, 0.7) (-0.5, 0.2) Cholesterol (g/1000 kcal) 122 (114, 131) 130 (118, 143) 9 (-4, 21) (-2, 24) (129, 151) 126 (116, 137) -7 (-17, 3) (4, 19) Alcohol (% kcal) 2.8 (2.1, 3.5) 2.5 (1.7, 3.2) -0.3 (-0.8, 0.1) (-0.4, 0.4) (1.7, 3) 2.9 (2.1, 3.8) 0.1 (-0.5, 0.6) (-0.9, 0.5) Fruit servings 1.4 (1.2, 1.6) 1.9 (1.6, 2.2) 0.5 (0.2, 0.8) (-0.6, 0.1) (1.2, 1.7) 2 (1.7, 2.3) 0.4 (0.1, 0.7) (-0.9, -0.4) <.0001 Vegetable servings 1.3 (1.1, 1.5) 2 (1.6, 2.3) 0.6 (0.3, 0.9) < (-0.5, 0.1) (1.3, 1.8) 2.3 (2, 2.6) 0.6 (0.3, 0.9) (-0.8, -0.2) <.001 Whole grain servings 1.5 (1.4, 1.7) 1.6 (1.4, 1.9) 0 (-0.2, 0.3) (-0.5, 0) (1.3, 1.6) 2.1 (1.8, 2.3) 0.6 (0.3, 0.8) < (-0.7, -0.2) Low fat dairy servings 0.6 (0.5, 0.7) 0.7 (0.5, 0.9) 0 (-0.2, 0.2) (-0.4, 0) (0.5, 0.7) 0.7 (0.5, 0.8) 0 (-0.1, 0.2) (-0.1, 0.2) Nuts (g) 11 (7.6, 14.4) 12.9 (9.1, 16.6) 4.2 (0.6, 7.8) (-1.1, 5) (5.8, 10.3) 12.4 (8.6, 16.3) 3.3 (-0.7, 7.3) (-5.4, 1.8) Soy protein (g) 1.6 (1, 2.1) 2.1 (1.2, 3) 0.1 (-0.9, 1.1) (-0.9, 0.7) (0.8, 2) 2 (1.2, 2.8) 0.3 (-0.5, 1.1) (-3.3, -1.1) <.001 Viscous Fiber (g) 0.3 (0.2, 0.5) 0.4 (0.3, 0.6) 0.1 (-0.2, 0.4) (-0.6, 0) (0.1, 0.4) 0.8 (0.6, 1.1) 0.6 (0.3, 0.9) < (-1.3, -0.5) <.0001 Data are means (95% CI). 4 people were missing dietary data at baseline, 27 people at 6 months, and 21 people at 18 months. Whole grain servings calculated as grams of whole grains from FFQ divided by 30. One low fat dairy serving = 1 cup low fat milk or yogurt, 1.5oz low fat cheese, or ½ cup cottage cheese Pr > t 12

13 Supplementray Table 6. Mean baseline values and changes in outcomes at 18 months for all participants 1 Baseline 18 months 18 month change 6 to 18 month change N Mean 95% CI Mean 95% CI Mean 95% CI Pr > t Mean 95% CI Pr > t Weight (kg) < BMI (kg/m2) < Waist (cm) < Glucose (mmol/l) Total Cholesterol (mmol/l) LDL-c (mmol/l) HDL-c (mmol/l) < <.0001 Triglycerides (mmol/l) Total Cholesterol/HDL Non-HDL Cholesterol (mmol/l) Systolic blood pressure < Diastolic blood pressure < Mean arterial pressure < Year CHD risk % To convert the values to milligrams per deciliter, divide cholesterol by , triglycerides by and glucose by

14 Supplementary Table 7. Mean values and changes (95% CI) in outcomes at baseline and 18 months for the control and three treatment groups 1 Control (N=486) Food Only (N=148) Baseline 18 months 18 month Pr > t 6 to 18 month Pr > t Baseline 18 months 18 month Pr > t 6 to 18 month Pr > t Weight (kg) 88 (86.5, 89.5) 87.2 (85.7, 88.8) -0.8 (-1.3, -0.2) (-0.4, 0.9) (86.3, 92.2) 87.9 (85.1, 90.8) -1.3 (-2.3, -0.3) (-1, 0.8) BMI (kg/m2) 32.5 (32, 33) 32.3 (31.7, 32.8) -0.2 (-0.4, -0.1) (-0.1, 0.3) (31.6, 33.5) 32.2 (31.3, 33.1) -0.4 (-0.8, 0) (-0.4, 0.3) Waist (cm) (100, 102.5) 99.7 (98.4, 101.1) -1.5 (-2.3, -0.7) (-1.3, 0.7) (99.8, 104.8) (98.1, 103.1) -1.7 (-2.9, -0.6) (-0.9, 1.3) Glucose (mmol/l) 4.81 (4.77, 4.86) 4.83 (4.77, 4.89) 0.01 (-0.03, 0.06) (-0.08, 0.07) (4.71, 4.89) 4.82 (4.72, 4.91) 0.02 (-0.07, 0.1) (-0.09, 0.09) Total Cholesterol (mmol/l) 5.09 (5, 5.17) 5.08 (4.98, 5.17) (-0.08, 0.06) (-0.04, 0.12) (4.87, 5.14) 5.03 (4.87, 5.19) 0.03 (-0.08, 0.13) (-0.05, 0.18) LDL-c (mmol/l) 3.27 (3.19, 3.34) 3.19 (3.1, 3.27) (-0.15, -0.01) (-0.11, 0.03) (3.06, 3.29) 3.16 (3.02, 3.3) (-0.11, 0.09) (-0.11, 0.1) HDL-c (mmol/l) 1.27 (1.24, 1.3) 1.32 (1.29, 1.35) 0.05 (0.03, 0.07) < (0.04, 0.08) < (1.21, 1.32) 1.3 (1.24, 1.36) 0.03 (0, 0.07) (-0.01, 0.07) Triglycerides (mmol/l) 1.23 (1.16, 1.29) 1.25 (1.17, 1.33) 0.03 (-0.04, 0.1) (-0.06, 0.13) (1.1, 1.32) 1.23 (1.11, 1.35) 0.02 (-0.06, 0.11) (-0.06, 0.14) Total Cholesterol/HDL 4.2 (4.1, 4.3) 4.05 (3.93, 4.16) (-0.24, -0.06) (-0.25, -0.05) (3.99, 4.38) 4.11 (3.9, 4.31) (-0.2, 0.04) (-0.19, 0.07) Non-HDL Cholesterol (mmol/l) 3.81 (3.73, 3.9) 3.76 (3.67, 3.85) (-0.12, 0.01) (-0.09, 0.05) (3.6, 3.87) 3.74 (3.58, 3.89) 0 (-0.1, 0.1) (-0.06, 0.14) Systolic blood pressure (113.6, 115.8) (112.5, 114.9) -1 (-2, 0) (-1.1, 0.8) (112.7, 116.5) (111, 114.9) -1.7 (-3.3, 0) (-3.6, -0.1) Diastolic blood pressure 73.3 (72.5, 74) 71.7 (70.7, 72.8) -1.5 (-2.5, -0.6) (-1.5, 0.4) (71.6, 74.2) 71.2 (69.7, 72.7) -1.7 (-2.9, -0.5) (-2.3, 0.5) Mean arterial pressure 87.1 (86.2, 87.9) 85.7 (84.7, 86.6) -1.4 (-2.2, -0.6) (-1.3, 0.2) (85.4, 88.2) 85.1 (83.6, 86.7) -1.7 (-2.9, -0.4) (-2.6, 0.3) Year CHD risk % 3.55 (3.21, 3.89) 3.37 (3.01, 3.73) (-0.36, 0) (-0.32, 0.06) (3.1, 4.54) 3.58 (2.91, 4.24) (-0.51, 0.03) (-0.33, 0.16) Advice Only (N=145) Food and Advice (N=140) Baseline 18 months 18 month Pr > t 6 to 18 month Pr > t Baseline 18 months 18 month Pr > t 6 to 18 month Pr > t Weight (kg) 86.2 (83.3, 89.1) 85.2 (82.3, 88.1) -1 (-1.8, -0.1) (-0.9, 1.3) (86.6, 92.6) 88.9 (85.7, 92.1) -0.7 (-1.8, 0.4) (-0.9, 1.1) BMI (kg/m2) 31.7 (30.8, 32.7) 31.4 (30.4, 32.4) -0.3 (-0.8, 0.1) (-0.5, 0.7) (31.7, 33.7) 32.4 (31.3, 33.4) -0.3 (-0.7, 0.1) (-0.3, 0.4) Waist (cm) (98.3, 102.8) 99.3 (96.9, 101.7) -1.3 (-2.4, -0.1) (-0.8, 2) (99.5, 104.3) (98.1, 103.6) -1 (-2.4, 0.4) (-1.3, 1.4) Glucose (mmol/l) 4.87 (4.77, 4.97) 4.87 (4.74, 5) 0 (-0.11, 0.11) (-0.1, 0.13) (4.72, 4.9) 4.86 (4.69, 5.03) 0.05 (-0.1, 0.2) (-0.09, 0.2) Total Cholesterol (mmol/l) 5.17 (5.02, 5.32) 5.2 (5.04, 5.36) 0.03 (-0.09, 0.15) (-0.19, 0.24) (4.74, 5.04) 4.86 (4.7, 5.02) (-0.14, 0.08) (-0.08, 0.15) LDL-c (mmol/l) 3.3 (3.17, 3.43) 3.25 (3.09, 3.41) (-0.19, 0.09) (-0.16, 0.13) (2.94, 3.2) 2.99 (2.84, 3.15) (-0.2, 0.04) (-0.12, 0.12) HDL-c (mmol/l) 1.32 (1.26, 1.39) 1.36 (1.29, 1.43) 0.04 (-0.02, 0.09) (-0.01, 0.13) (1.24, 1.36) 1.33 (1.27, 1.39) 0.03 (-0.01, 0.07) (0.02, 0.09) Triglycerides (mmol/l) 1.2 (1.1, 1.31) 1.27 (1.12, 1.42) 0.07 (-0.07, 0.21) (-0.14, 0.19) (1.03, 1.26) 1.19 (1.06, 1.31) 0.04 (-0.06, 0.14) (-0.12, 0.09) Total Cholesterol/HDL 4.16 (3.97, 4.35) 4.01 (3.82, 4.2) (-0.28, -0.02) (-0.3, -0.05) (3.8, 4.18) 3.87 (3.67, 4.08) (-0.28, 0.04) (-0.25, 0.07) Non-HDL Cholesterol (mmol/l) 3.85 (3.71, 3.99) 3.84 (3.67, 4) (-0.14, 0.12) (-0.18, 0.16) (3.45, 3.74) 3.55 (3.41, 3.69) (-0.14, 0.06) (-0.11, 0.13) Systolic blood pressure (112.8, 116.7) 113 (110.9, 115.1) -1.8 (-3.3, -0.2) (-2.6, 1.7) (111.8, 116.1) (110.3, 114.5) -1.6 (-3.3, 0.2) (-3.7, 0.4) Diastolic blood pressure 72.2 (70.8, 73.6) 70.4 (68.8, 71.9) -1.8 (-3, -0.7) (-2.3, 0.5) (71.2, 74.2) 71.5 (70, 73) -1.2 (-2.5, 0.1) (-2.4, 0.3) Mean arterial pressure 86.4 (84.9, 87.9) 84.3 (82.4, 86.1) -2.1 (-3.7, -0.5) (-3.2, 1.2) (84.9, 88.1) 85.6 (83.9, 87.2) -0.9 (-2.2, 0.5) (-2.4, 0.7) Year CHD risk % 4.03 (3.35, 4.71) 3.67 (2.96, 4.37) (-0.84, 0.11) (-0.76, 0.4) (2.29, 3.59) 2.66 (2.08, 3.23) (-0.57, 0) (-0.41, 0.06) To convert the values to milligrams per deciliter, divide cholesterol by , triglycerides by and glucose by

15 Supplementary Table 8. Treatment differences in outcomes (differences in change) at 6 and 18 months for the control and three treatment groups. Household treated as unit of analysis. 0 to 6 Months 0 to 18 Months 6 to 18 Months Treatment Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Weight (kg) A C A FA BMI (kg/m2) Waist (cm) Glucose (mmol/l) Total Cholesterol (mmol/l) LDL-c (mmol/l) HDL-c (mmol/l) A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F Household treated as unit of measure by taking the mean of individual measurements within each household. To convert the values to milligrams per deciliter, divide cholesterol by , triglycerides by and glucose by Treatments: C, control; A, advice; F, food delivery; FA, and food delivery and advice 15

16 Supplementary Table 8. Treatment differences in outcomes (differences in change) at 6 and 18 months for the control and three treatment groups. Household treated as unit of analysis. 0 to 6 Months 0 to 18 Months 6 to 18 Months Treatment Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Estimate Lower Upper Pr > t Triglycerides (mmol/l) A C A FA Total Cholesterol/HDL-c Non-HDL-c (mmol/l) Systolic blood pressure Diastolic blood pressure Mean Arterial Pressure 10 year CHD risk (%) A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F A C A FA A F C FA C F FA F Household treated as unit of measure by taking the mean of individual measurements within each household. To convert the values to milligrams per deciliter, divide cholesterol by , triglycerides by and glucose by Treatments: C, control; A, advice; F, food delivery; FA, and food delivery and advice 16