Background
Methods
Study overview
Participants
Lifestyle study intervention
Phase I (months 1–6) diet and PA intervention
Food | PREDIMED Diet goal | Med-South Diet goal |
---|---|---|
1--Vegetable Oil | Olive oil group: ≥ 4 tbsp/day extra virgin olive oil | 2–6 servings/day of foods high in healthy fats (nuts, fish, full fat salad dressings and spreads, other foods prepared with olive or vegetable oils, and vegetables with high fat content such as avocado) |
2--Tree nuts and peanuts
|
Nut group: ≥ 3 servings/wk
b
|
≥3 servings/wk
|
3--Fresh fruits
|
≥3 servings/day
|
≥7 servings for fruits and vegetables/day
|
4--Vegetables
|
≥3 servings/day
| |
5--Fish (especially fatty fish), seafood | ≥3 servings/wk | ≥1 servings/wk |
6--Legumes
|
≥3 servings/wk
|
≥3 servings/wk
|
7--Sofritob | ≥2 servings/wk | No recommendation |
8--White meat
|
Instead of red meat
|
Consume poultry often
|
9--Wine with meals (optional, only for habitual drinkers)
|
≥7 glasses/wk
|
Do not recommend starting wine consumption, but provide information on effects of alcohol for heart health, suggesting up to 1 serving a day for females and up to 2 for males
|
10--Soda drinks
|
<1 drink/day
|
<1 drink/day
|
11--Commercial bakery goods, sweets, and pastries
|
<3 servings/wk
|
<3 servings/wk
|
12--Spread fats | <1 serving/day | Up to several servings/day of trans fat free spreads |
13--Red and processed meats
|
<1 serving/day
|
≤1 serving/day
|
Phase II (months 7–12)--weight loss and lifestyle maintenance intervention
Phase III (months 13–24)-- weight loss and lifestyle maintenance interventions
High BP study intervention
Measures
Sample size, randomization, and statistical analysis
Results
Enrollment and baseline characteristics of participants
Characteristics | Overall | Raceb | Participant selected intervention groupc | |||
---|---|---|---|---|---|---|
African | White | Lifestyle | Weight loss, group | Weight loss, combination | ||
American | ||||||
n = 339 | n = 219 | n = 117 | n = 160 | n = 57 | n = 81 | |
Demographics | ||||||
Age, mean (SE) | 56 (0.6) | 54 (0.8) | 58 (1.0) | 57 (1.0) | 53 (1.3) | 55 (1.1) |
Female sex | 260 (77) | 181 (83) | 76 (65) | 110 (69) | 52 (91) | 72 (89) |
Race | ||||||
African American | 101 (63) | 41 (72) | 62 (79) | |||
White | 58 (37) | 16 (28) | 17 (21) | |||
Education, y | ||||||
≤ 8 (middle school or less) | 16 (5) | 11 (5) | 5 (4) | 11 (7) | 1 (2) | 2 (3) |
9–11 (some high school) | 45 (13) | 35 (16) | 9 (8) | 27 (17) | 5 (9) | 9 (11) |
12 (high school graduate) | 128 (38) | 94 (43) | 34 (29) | 60 (37) | 20 (35) | 33 (41) |
13–15 (some college) | 79 (23) | 45 (21) | 33 (28) | 35 (22) | 15 (26) | 18 (22) |
16 (college graduate) | 49 (14) | 26 (12) | 22 (19) | 17 (11) | 11 (19) | 13 (16) |
> 16 (graduate school) | 22 (7) | 8 (4) | 14 (12) | 10 (6) | 5 (9) | 6 (7) |
Education: high school or less | 189 (56) | 140 (64) | 48 (41) | 98 (61) | 26 (46) | 44 (54) |
Marital status | ||||||
Married or living with a partner | 159 (47) | 82 (37) | 76 (65) | 69 (43) | 23 (40) | 41 (51) |
Other | 180 (53) | 137 (63) | 41 (35) | 91 (57) | 34 (60) | 40 (49) |
Currently have health insurance | 251 (74) | 156 (71) | 92 (79) | 117 (73) | 45 (79) | 58 (72) |
Current employment | ||||||
Working full time | 124 (37) | 82 (37) | 40 (34) | 46 (29) | 29 (51) | 38 (47) |
Working part time | 42 (12) | 31 (14) | 10 (8) | 23 (14) | 4 (7) | 10 (12) |
Do not work due to health reasons | 69 (20) | 43 (20) | 26 (22) | 37 (23) | 9 (16) | 16 (20) |
Retired | 53 (16) | 26 (12) | 27 (23) | 29 (18) | 7 (12) | 8 (10) |
Other | 51 (15) | 37 (17) | 14 (12) | 25 (16) | 8 (14) | 9 (11) |
Annual household income | ||||||
< $10,000 | 62 (20) | 50 (26) | 11 (10) | 40 (29) | 6 (11) | 9 (11) |
$10,000 to < $20,000 | 64 (21) | 45 (23) | 19 (17) | 29 (21) | 11 (21) | 18 (23) |
$20,000 to < $40,000 | 84 (28) | 60 (31) | 23 (21) | 32 (24) | 14 (26) | 27 (35) |
$40,000 to < $60,000 | 33 (11) | 15 (8) | 18 (17) | 11 (8) | 8 (15) | 9 (11) |
$60,000 to < $80,000 | 27 (9) | 13 (7) | 14 (13) | 11 (8) | 11 (21) | 5 (6) |
≥ $80,000 | 34 (11) | 10 (5) | 24 (22) | 13 (10) | 3 (6) | 10 (13) |
CVD and risk factors for CVD | ||||||
Known coronary heart disease | 49 (14) | 30 (14) | 19 (16) | 29 (18) | 5 (9) | 5 (6) |
Known CVD | 62 (18) | 37 (17) | 25 (21) | 34 (21) | 7 (12) | 8 (10) |
Hypertension | 291 (86) | 195 (89) | 95 (81) | 143 (89) | 47 (82) | 66 (81) |
Cholesterol category | ||||||
High (≥240 mg/dL) | 187 (56) | 110 (51) | 76 (65) | 88 (56) | 31 (55) | 47 (59) |
Borderline (200–239 mg/dL) | 46 (14) | 33 (15) | 12 (10) | 16 (10) | 11 (19) | 13 (16) |
Desirable (<200 mg/dL) | 102 (30) | 72 (33) | 29 (25) | 54 (34) | 15 (26) | 20 (25) |
Diabetes | 124 (37) | 89 (41) | 34 (29) | 62 (39) | 21 (37) | 27 (33) |
Current cigarette smoker | 54 (16) | 37 (17) | 17 (14) | 36 (22) | 4 (7) | 5 (6) |
Packs of cigarettes smoked per day, mean (SE) for current smokers | 0.7 (0.1) | 0.6 (0.1) | 0.9 (0.1) | 0.7 (0.1) | 0.6 (0.2) | 0.6 (0.3) |
Taking BP lowering medication | 260 (77) | 176 (80) | 83 (71) | 129 (81) | 43 (75) | 60 (74) |
Lifestyle mean (SE) | ||||||
DRA total score | 27.8 (0.3) | 28.0 (0.5) | 27.6 (0.4) | 27.8 (0.5) | 27.2 (0.7) | 27.6 (0.6) |
Fat quality screener score | 15.5 (0.2) | 15.4 (0.2) | 15.07 (0.3) | 15.4 (0.2) | 15.3 (0.3) | 15.4 (0.3) |
Fruit and vegetable, servings per day | 3.4 (0.1) | 3.4 (0.1) | 3.5 (0.2) | 3.5 (0.2) | 3.0 (0.3) | 3.5 (0.2) |
Carotenoid indexe, mean (SE) | 40.7 (1.3) | 41.9 (1.6) | 38.2 (2.5) | 41.1 (2.0) | 42.1 (3.5) | 39.1 (2.4) |
Walking time, min/wkf | 91 (11.3) | 100 (16.2) | 73 (11.8) | 110 (18.8) | 97 (26.5) | 55 (13.3) |
Activity time, min/wkg | 149 (14.0) | 150 (18.2) | 143 (21.5) | 160 (22.7) | 148 (29.1) | 135 (25.7) |
Physiologic mean (SE) | ||||||
Weight, kg | 98.1 (1.4) | 100 (1.7) | 94 (2.3) | 93.8 (2.0) | 101.3 (3.3) | 106.4 (2.6) |
BMI, kg/m2 | 36 (0.5) | 37 (0.6) | 34 (0.8) | 34 (0.7) | 38 (1.1) | 40 (1.0) |
Systolic BP, mm Hgh | 135 (1.2) | 136 (1.6) | 132 (1.8) | 138 (1.8) | 130 (2.6) | 133 (2.3) |
LS study only (n = 139) | 125 (1.3) | 126 (1.6) | 122 (2.2) | 124 (2.5) | 126 (2.7) | 126 (2.0) |
LS and HBP study (n = 200) | 142 (1.7) | 143 (2.2) | 139 (2.4) | 142 (2.2) | 137 (5.2) | 142 (4.0) |
Diastolic BP, mm Hg | 82 (0.7) | 83 (0.9) | 80 (1.0) | 83 (1.0) | 82 (1.4) | 81 (1.3) |
LS study only (n = 139) | 79 (0.8) | 80 (1.0) | 76 (1.4) | 77 (1.5) | 80 (1.5) | 79 (1.5) |
LS and HBP study (n = 200) | 84 (0.9) | 86 (1.3) | 83 (1.3) | 85 (1.2) | 87 (2.7) | 84 (2.2) |
HbA1c, % of total Hb | 6.6 (0.1) | 6.7 (0.1) | 6.2 (0.1) | 6.5 (0.1) | 6.9 (0.3) | 6.5 (0.2) |
Total cholesterol, mg/dL | 193 (2.3) | 191 (2.8) | 196 (4.0) | 191 (3.1) | 198 (6.0) | 189 (4.7) |
HDL cholesterol, mg/dL | 54 (0.8) | 57 (1.0) | 50 (1.4) | 55 (1.2) | 53 (1.8) | 53 (1.5) |
Phase I outcomes
Outcome | Phase 1 | |
---|---|---|
Baseline to 6 months | ||
(6 months minus baseline) | ||
n | Mean, 95 % CI | |
Dietary | ||
DRA total score | ||
All | 235 |
4.3 (3.7 to 5.0)
***
|
Subgroup by raceb | ||
--African American | 155 |
4.6 (3.7 to 5.5)
***
|
--White | 77 |
3.9 (2.9 to 5.0)
***
|
Fat quality screener score | ||
All | 229 |
1.4 (1.0 to 1.7)
***
|
--African American | 150 |
1.4 (0.9 to 1.8)
***
|
--White | 76 |
1.3 (0.7 to 2.0)
***
|
Fruit and vegetable servings per day | ||
All | 249 |
0.3 (0.1 to 0.5)
**
|
--African American | 168 | 0.2 (0.0 to 0.5) |
--White | 78 |
0.3 (0.0 to 0.7)
*
|
Carotenoid indexc | ||
All | 169 | −0.9 (−3.3 to 1.5) |
--African American | 118 | −0.2 (−2.8 to 2.5) |
--White | 49 | −3.5 (−8.7 to 1.8) |
Physical Activity | ||
Walking time, min/wkd | ||
All | 249 |
64 (19 to 109)
**
|
--African American | 168 |
65 (5 to 125)
*
|
--White | 78 |
66 (4 to 128)
*
|
Activity time, min/wke | ||
All | 249 |
97 (36 to 158)
**
|
--African American | 168 |
106 (28 to 184)
**
|
--White | 78 | 88(−13 to 188) |
Blood Pressure Medication | ||
Taking BP lowering medication, % | ||
All | 249 | 2.0 % (−0.3 to 4.4) |
--African American | 167 | 1.2 % (−1.7 to 4.1) |
--White | 78 | 3.8 % (−0.4 to 8.1) |
Physiologic | ||
Systolic BP, mm Hgf | ||
LS study only | 119 |
−4.7 (−6.9 to −2.6)
***
|
LS and HBP study | 130 |
−7.9 (−11.8 to 4.0)
***
|
All | 249 |
−6.4 (−8.7 to −4.1)
***
|
--African American | 168 |
−6.8 (−9.7 to −3.8)
***
|
--White | 78 |
−5.6 (−9.4 to −1.8)
**
|
Diastolic BP, mm Hg | ||
LS study only | 119 |
−2.8 (−4.2 to −1.3)
***
|
LS and HBP study | 130 |
−4.6 (−6.5 to −2.7)
***
|
All | 249 |
−3.7 (−4.9 to −2.5)
***
|
--African American | 168 |
−3.5 (−5.1 to −2.0)
***
|
--White | 78 |
−4 (−6.1 to −2.3)
***
|
Weight, kg | ||
All | 248 |
−0.7 (−1.2 to −0.3)
**
|
-African American | 167 |
−0.8 (−1.4 to −0.3)
**
|
--White | 78 | −0.4 (−1.3 to 0.5) |
Weight, ≥ 5 % weight loss, % | ||
All | 248 | 9 % (6 to 13) |
--African American | 167 | 12 % (7 to 17) |
--White | 78 | 4 % (0 to 8) |
Phase II outcomes
Outcome | Phase 2 | |||
---|---|---|---|---|
6 months to 12 months | Baseline to 12 months | |||
(12 months minus 6 months) | (12 months minus baseline) | |||
n | Mean, 95 % CI | n | Mean, 95 % CI | |
Dietary | ||||
DRA total score | ||||
All | 219 |
−0.7 (−1.3 to −0.1)
*
| 227 |
3.3 (2.5 to 4.0)
***
|
Subgroup by raceb | ||||
--African American | 151 | −0.2 (−1.0 to 0.6) | 156 |
4.0 (3.1 to 4.9)
***
|
--White | 66 |
−1.9 (−2.7 to −1.1)
***
| 69 |
1.7 (0.4 to 3.0)
**
|
Subgroup by interventionc | ||||
--Lifestyle | 93 | 0.0 (−1.0 to 0.9) | 102 |
1.7 (0.7 to 2.8)
***
|
--Wt loss, group | 51 | −0.3 (−1.5 to 0.9) | 51 |
5.1 (3.8 to 6.4)
***
|
--Wt loss, combination | 75 |
−1.7 (−2.8 to −0.7)
***
| 74 |
4.1 (2.7 to 5.6)
***
|
Fat quality screener score | ||||
All | 218 | −0.1 (−0.5 to 0.2) | 225 |
1.0 (06 to 1.3)
***
|
--African American | 150 | 0.1 (−0.3 to 0.5) | 154 |
1.2 (0.8 to 1.7)
***
|
--White | 66 |
−0.6 (−1.2 to −0.1)
*
| 69 | 0.4 (−0.2 to 1.0) |
--Lifestyle | 93 | 0.2 (−0.4 to 0.8) | 102 |
0.7 (0.1 to 1.2)
*
|
--Wt loss, group | 51 | −0.1 (−0.8 to 0.5) | 48 |
1.3 (0.6 to 2.0)
***
|
--Wt loss, combination | 74 |
−0.6 (−1.1 to −0.1)
*
| 75 |
1.2 (0.6 to 1.8)
***
|
Fruit and vegetable servings per day | ||||
All | 221 |
0.4 (0.2 to 0.5)
***
| 253 |
0.5 (0.3 to 0.8)
***
|
--African American | 153 |
0.5 (0.2 to 0.7)
***
| 178 |
0.5 (0.2 to 0.9)
**
|
--White | 66 | 0.0 (−0.3 to 0.3) | 73 |
0.5 (0.1 to 0.9)
**
|
--Lifestyle | 95 | 0.1 (−0.2 to 0.4) | 127 | 0.1 (−0.2 to 0.5) |
--Wt loss, group | 51 |
0.5 (0.1 to 0.9)
*
| 51 |
1.0 (0.5 to 1.5)
***
|
--Wt loss, combination | 75 |
0.6 (0.2 to 0.9)
***
| 75 |
0.9 (0.4 to 1.3)
***
|
Carotenoid indexd | ||||
All | 105 | 3.7 (0.4 to 6.9) | 117 |
3.1 (−0.4 to 6.7)
*
|
--African American | 77 | 3.1 (−0.8 to 7.1) | 88 | 3.0 (−1.4 to 7.5) |
--White | 27 |
5.6 (−0.4 to 11.7)
*
| 28 | 3.4 (−2.0 to 8.9) |
--Lifestyle | 33 | 5.6 (−0.2 to 11.9) | 40 | 3.1 (−3.2 to 9.5) |
--Wt loss, group | 29 | 1.9 (−3.5 to 7.3) | 31 | 3.7 (−3.0 to 10.4) |
--Wt loss, combination | 43 | 3.2 (−2.0 to 8.4) | 46 | 2.7 (−2.9 to 8.3) |
Physical Activity | ||||
Walking time, min/wke | ||||
All | 221 | 7 (−49 to 63) | 253 |
71 (28 to 113)
***
|
--African American | 153 | 16 ((−59 to 91) | 178 |
68 (13 to 123)
*
|
--White | 66 | −14 (−88 to 61) | 73 |
82 (23 to 142)
**
|
--Lifestyle | 95 | 29 (−56 to 113) | 127 | 60 (−10 to 130) |
--Wt loss, group | 51 | −21 (−164 to 123) | 51 | 66 (−27 to 158) |
--Wt loss, combination | 75 | −2 (−81 to 77) | 75 |
93 (45 to 141)
***
|
Activity time, min/wkf | ||||
All | 221 | −26 (−96 to 44) | 253 |
83 (30 to 136)
**
|
--African American | 153 | −19 (−115 to 77) | 178 |
75 (14 to 136)
*
|
--White | 66 | −42 (−115 to 32) | 73 |
110 (2 to 218)
*
|
--Lifestyle | 95 | 3 (−84 to 90) | 127 | 67 (−24 to 158) |
--Wt loss, group | 51 | −90 (−310 to 131) | 51 |
108 (9 to 208)
*
|
--Wt loss, combination | 75 | −19 (−105 to 66) | 75 |
93 (35 to 151)
**
|
Outcome | Phase 2 | |||
---|---|---|---|---|
6 months to 12 months | Baseline to 12 months | |||
(12 months minus 6 months) | (12 months minus baseline) | |||
n | Mean, 95 % CI | n | Mean, 95 % CI | |
Blood Pressure Medication | ||||
Taking BP lowering medication, % | ||||
All | 221 | −0.5 % (−2.8 to 1.9) | 253 | 0.0 % (−3.3 to 3.3) |
--African American | 153 | 0.0 % (−3.1 to 3.1) | 178 | −0.6 % (−4.5 to 3.4) |
--White | 66 | −1.5 % (−4.5 to 1.4) | 73 | 1.4 % (−4.6 to 7.4) |
--Lifestyle | 95 | −1.0 % (−3.1 to 1.0) | 127 | −0.8 % (−5.4 to 3.8) |
--Wt loss, group | 51 | −2.0 % (−8.6 to 4.7) | 51 | −2.0 % (−10.5 to 6.6) |
--Wt loss, combination | 75 | 1.3 % (−3.2 to 5.8) | 75 | 2.7 % (−2.5 to 7.9) |
Physiologic | ||||
Systolic BP, mm Hg | ||||
LS study only | 99 |
3.2 (0.3 to 6.2)
*
| 101 | −1.4 (−4.5 to 1.6) |
LS and HBP study | 121 | −2.5 (−6.5 to 1.4) | 150 |
−9.3 (−13.6 to −5.1)
***
|
All | 220 | 0.0 (−2.5 to 2.6) | 251 |
−6.1 (−9.0 to −3.3)
***
|
Subgroup by raceb | ||||
--African American | 152 | −0.9 (−4.0 to 2.1) | 176 |
−6.9 (−10.5 to −3.3)
***
|
--White | 66 | 2.5 (−2.5 to 7.4) | 73 | −4.2 (−8.8 to 0.3) |
Subgroup by interventionc | ||||
--Lifestyle | 95 | −2.2 (−6.2 to 1.8) | 126 |
−8.3 (−12.6 to −3.9)
***
|
--Wt loss, group | 50 | 3.3 (−1.0 to 7.6) | 50 | −3.6 (−7.8 to 0.5) |
--Wt loss, combination | 75 | 0.7 (−3.8 to 5.3) | 75 | −4.3 (−9.7 to 1.1) |
Diastolic BP, mm Hg | ||||
LS study only | 99 | 0.4 (−1.4 to 2.2) | 101 |
−2.0 (−3.7 to −0.4)
*
|
LS and HBP study | 121 |
−3.1 (−5.3 to −1.0)
**
| 150 |
−7.0 (−9.0 to −4.9)
***
|
All | 220 |
−1.5 (−2.9 to −0.1)
*
| 251 |
−5.0 (−6.4 to −3.6)
***
|
--African American | 152 |
−2.3 (−4.0 to −0.5)
**
| 176 |
−5.2 (−7.0 to −3.4)
***
|
--White | 66 | 0.7 (−1.8 to 3.2) | 73 |
−4.2 (−6.4 to −1.9)
***
|
--Lifestyle | 95 | −2.2 (−4.4 to 0.1) | 126 |
−5.4 (−7.5 to −3.2)
***
|
--Wt loss, group | 50 | 1.2 (−1.0 to 3.4) | 50 |
−4.2 (−6.9 to −1.6)
**
|
--Wt loss, combination | 75 | −2.5 (−5.1 to 0.1) | 75 |
−4.5 (−7.2 to −2.3)
***
|
Weight, kg | ||||
All | 219 |
−1.1 (−1.7 to −0.5)
***
| 250 |
−1.7 (−2.5 to 1.0)
***
|
--African American | 151 |
−0.9 (−1.6 to −0.3)
**
| 175 |
−1.7 (−2.6 to −0.8)
***
|
--White | 66 |
−1.4 (−2.3 to −0.3)
*
| 73 |
−1.6 (−3.1 to −0.2)
*
|
--Lifestyle | 94 | −0.3 (−1.3 to 0.6) | 125 | −0.9 (−2.1 to 0.2) |
--Wt loss, group | 50 |
−1.3 (−2.4 to −0.2)
*
| 50 |
−3.1 (−4.9 to −1.3)
***
|
--Wt loss, combination | 75 |
−1.9 (−2.8 to −1.0)
***
| 75 |
−2.1 (−3.2 to −1.0)
***
|
Weight, ≥ 5 % weight loss, % | ||||
All | 219 | 18 % (13 to 23) | 250 | 23 % (18 to 28) |
--African American | 151 | 18 % (12 to 24) | 175 | 23 % (17 to 30) |
--White | 66 | 18 % (9 to 28) | 73 | 22 % (12 to 31) |
--Lifestyle | 94 | 14 % (7 to 21) | 125 | 19 % (12 to 26) |
--Wt loss, group | 50 | 22 % (10 to 34 | 50 | 34 % (21 to 47) |
--Wt loss, combination | 75 | 21 % (12 to 31) | 75 | 23 % (13 to 32) |
Total cholesterol, mg/dLd | ||||
All | 221 | −3 (−7.0 to 0.7) | ||
--African American | 155 | −4 (−8.5 to 0.4) | ||
--White | 64 | 0 (−7.8 to 7.7) | ||
--Lifestyle | 106 | −3 (−9.1 to 2.7) | ||
--Wt loss, group | 44 | −6 (−13.5 to 1.4) | ||
--Wt loss, combination | 71 | −1 (−8.0 to 5.2) | ||
HDL cholesterol, mg/dL | ||||
All | 220 |
−2 (−2.8 to −0.4)
**
| ||
--African American | 154 |
−2 (−3.0 to 0)
*
| ||
--White | 64 | −2 (−3.8 to 0.3) | ||
--Lifestyle | 106 | −2 (−3.8 to −0.1) | ||
--Wt loss, group | 44 | −1 (−3.1 to 1.5) | ||
--Wt loss, combination | 70 | −1 (−3.5 to 0.5) |
Phase III outcomes
Outcome | Phase 3 | |||
---|---|---|---|---|
12 months to 24 months | Baseline to 24 months | |||
(24 months minus 12 months) | (24 months minus baseline) | |||
n | Mean, 95 % CI | n | Mean, 95 % CI | |
Dietary | ||||
DRA total score | ||||
All | 236 | −0.3 (−0.8 to 0.2) | 226 |
2.9 (2.3 to 3.6)
***
|
Subgroup by raceb | ||||
--African American | 168 |
−0.7 (−1.3 to 0.0)
*
| 158 |
3.0 (2.2 to 3.8)
***
|
--White | 66 | 0.6 (−0.2 to 1.4) | 66 |
2.8 (1.6 to 4.0)
***
|
Subgroup by interventionc | ||||
--Lifestyle | 116 | −0.1 (−0.8 to 0.6) | 105 |
1.8 (0.9 to 2.7)
***
|
--Wt loss, group | 48 |
−1.1 (−2.1 to −0.2)
*
| 50 |
4.0 (2.7 to 5.4)
***
|
--Wt loss, combination | 72 | 0.0 (−0.9 to 1.0) | 71 |
3.9 (2.6 to 5.2)
***
|
Fat quality screener score | ||||
All | 236 |
−0.4 (−0.7 to 0)
*
| 224 |
0.7 (0.3 to 1.0)
***
|
--African American | 168 | −0.6 (−1.0 to −0.1)** | 156 |
0.7 (0.2 to 1.1)
**
|
--White | 66 | 0.1 (−0.5 to 0.6) | 66 | 0.6 (−0.2 to 1.5) |
--Lifestyle | 116 |
−0.7 (−1.3 to −0.2)
**
| 105 | 0.1 (−0.5 to 0.7) |
--Wt loss, group | 48 | −0.2 (−0.9 to 0.5) | 47 |
1.2 (0.4 to 2.0)
**
|
--Wt loss, combination | 72 | 0.1 (−0.5 to 0.6) | 72 |
1.1 (0.5 to 1.7)
***
|
Fruit and vegetable servings per day | ||||
All | 237 | −0.2 (−0.4 to 0.1) | 250 |
0.4 (0.2 to 0.6)
***
|
--African American | 169 | −0.2 (−0.5 to 0.1) | 177 |
0.3 (0.1 to 0.6)
*
|
--White | 66 | 0.0 (−0.4 to 0.3) | 71 |
0.5 (0.1 to 0.8)
**
|
--Lifestyle | 117 | 0.1 (−0.2 to 0.4) | 127 | 0.2 (−0.1 to 0.5) |
--Wt loss, group | 48 | −0.1 (−0.6 to 0.3) | 51 |
0.9 (0.4 to 1.4)
***
|
--Wt loss, combination | 72 |
−0.5 (−0.9 to −0.1)
**
| 72 | 0.3 (−0.1 to 0.8) |
Physical Activity | ||||
Walking time, min/wkd | ||||
All | 237 |
−52 (−89 to −15)
**
| 250 | 22 (−13 to 56) |
--African American | 169 |
−49 (−95 to −3)
*
| 177 | 21 (−25 to 67) |
--White | 66 |
−63 (−123 to −2)
*
| 71 | 27 (−12 to 65) |
--Lifestyle | 117 | −55 (−111 to 2) | 127 | 8 (−50 to 65) |
--Wt loss, group | 48 |
−81 (−163 to 0)
*
| 51 | −4 (−69 to 60) |
--Wt loss, combination | 72 | −29 (−84 to 27) | 72 |
65 (22 to 108)
**
|
Activity time, min/wke | ||||
All | 237 | −40 (−91 to 11) | 250 | 48 (−7 to 103) |
--African American | 169 | −25 (−89 to 40) | 177 | 54 (−17 to 124) |
--White | 66 |
−82 (−164 to −0.5)
*
| 71 | 39 (−46 to 124) |
--Lifestyle | 117 | −17 (−106 to 73) | 127 | 51 (−46 to 149) |
--Wt loss, group | 48 |
−116 (−208 to −24)
**
| 51 | 12 (−70 to 95) |
--Wt loss, combination | 72 | −27 (−84 to 29) | 72 |
68 (7 to 129)
*
|
Outcome | Phase 3 | |||
---|---|---|---|---|
12 months to 24 months | Baseline to 24 months | |||
(24 months minus 12 months) | (24 months minus baseline) | |||
n | Mean, 95 % CI | n | Mean, 95 % CI | |
Blood Pressure Medication | ||||
Taking BP lowering medication, % | ||||
All | 237 | 0.4 % (−2.3 to 3.2) | 250 | 0.8 % (−3.0 to 4.6) |
--African American | 169 | 1.2 %(−1.6 to 4.0) | 177 | 1.1 % (−3.3 to 5.6) |
--White | 66 | 0.0 % (−5.9 to 5.9) | 71 | 1.4 % (−5.9 to 8.7) |
--Lifestyle | 117 | 2.6 % (−1.1 to 6.3) | 127 | 1.6 % (−4.2 to 7.3) |
--Wt loss, group | 48 | 2.1 % (−5.0 to 9.1) | 51 | 2.0 % (−6.6 to 10.5) |
--Wt loss, combination | 72 | −4.2 % (−8.8 to 0.4) | 72 | −1.4 % (−7.5 to 4.7) |
Physiologic | ||||
Systolic BP, mm Hg | ||||
LS study only | 95 | −2.8 (−6.4 to 0.7) | 104 |
−4.2 (−7.3 to 1.2)
**
|
LS and HBP study | 140 | −0.2 (−3.8 to 3.5) | 146 |
−9.4 (−13.4 to −5.4)
***
|
All | 235 | −1.3 (−3.9 to 1.3) | 250 |
−7.2 (−9.9 to −4.6)
***
|
Subgroup by raceb | ||||
--African American | 167 | −2.0 (−5.3 to 1.2) | 177 |
−8.4 (−11.8 to −5.1)
***
|
--White | 66 | 0.9 (−3.3 to 5.2) | 71 | −4.1 (−8.5 to 0.4) |
Subgroup by interventionc | ||||
--Lifestyle | 116 | −1.2 (−4.9 to 2.5) | 127 |
−8.8 (−12.9 to −4.8)
***
|
--Wt loss, group | 47 | 0.4 (−3.9 to 4.8) | 51 | −3.9 (−8.4 to 0.6) |
--Wt loss, combination | 72 | −2.4 (−7.8 to 2.9) | 72 |
−6.8 (−11.8 to −1.9)
**
|
Diastolic BP, mm Hg | ||||
LS study only | 95 |
−3.4 (−5.4 to −1.5)
***
| 104 |
−5.2 (−7.1 to −3.3)
***
|
LS and HBP study | 140 | −0.9 (−2.9 to 1.0) | 146 |
−7.8 (−10.1 to −5.5)
***
|
All | 235 | −1.9 (−3.4 to −0.5) | 250 |
−6.7 (−8.3 to −5.1)
***
|
--African American | 167 |
−2.4 (−4.2 to 0.5)
**
| 177 |
−7.2 (−9.2 to −5.1)
***
|
--White | 66 | −1.0 (−3.0 to 1.0) | 71 |
−5.4 (−7.6 to −3.3)
***
|
--Lifestyle | 116 | −1.9 (−4.0 to 0.2) | 127 |
−6.8 (−9.1 to −4.4)
***
|
--Wt loss, group | 47 |
−3.1 (−5.8 to −0.4)
*
| 51 |
−7.7 (−10.7 to −4.6)
***
|
--Wt loss, combination | 72 | −1.3 (−3.9 to 1.3) | 72 |
−6.0 (−8.8 to −3.2)
***
|
Weight, kg | ||||
All | 232 | 0.1 (−0.6 to 0.8) | 247 |
−1.6 (−2.5 to −0.7)
***
|
--African American | 164 | −0.1 (−1.0 to .08) | 174 |
−1.8 (−2.8 to −0.8)
***
|
--White | 66 | 0.6 (−0.6 to 1.7) | 71 | −1.0 (−2.9 to 0.8) |
--Lifestyle | 113 | −0.9 (−2.0 to 0.1) | 124 |
−1.7 (−2.9 to −0.5)
**
|
--Wt loss, group | 47 | 1.2 (−0.4 to 2.8) | 51 |
−2.1 (−4.3 to 0.0)
*
|
--Wt loss, combination | 72 | 1.0 (−0.2 to 2.2) | 72 | −1.1 (−2.7 to 0.4) |
Weight, ≥ 5 % weight loss, % | ||||
All | 232 | 12 % (8 to 16) | 247 | 23 % (18 to 28) |
--African American | 164 | 12 % (7 to 17) | 174 | 24 % (18 to 31) |
--White | 66 | 12 % (4 to 20) | 71 | 18 % (9 to 27) |
--Lifestyle | 113 | 16 % (9 to 23) | 124 | 23 % (16 to 31) |
--Wt loss, group | 47 | 11 % (2 to 20) | 51 | 25 % (13 to 38) |
--Wt loss, combination | 72 | 7 % (1 to 13) | 72 | 21 % (11 to 30) |
Total cholesterol, mg/dLd | ||||
All | 196 | 1 (−3.3 to 5.0) | 211 | −3 (−7.8 to 1.7) |
--African American | 139 | −1 (−6.3 to 4.7) | 148 | −4 (−10.3 to 1.4) |
--White | 55 | 4 (−0.9 to 9.8) | 61 | 1 (−7.3 to 9.2) |
--Lifestyle | 91 | 2 (−4.0 to 8.8) | 99 | −2 (−8.1 to 4.3) |
--Wt loss, group | 41 | −3 (−13.7 to 7.2) | 46 | −9 (−20.9 to 3.7) |
--Wt loss, combination | 64 | 1 (−4.7 to 7.1) | 66 | −1 (−9.3 to 7.2) |
HDL cholesterol, mg/dL | ||||
All | 196 | 0 (−0.8 to 1.3) | 211 | −1 (−2.3 to 0.3) |
--African American | 139 | 0 (−1.2 to 1.6) | 148 | −1 (−2.6 to 0.6) |
--White | 55 | 0 (−1.4 to 2.2) | 61 | −1 (−3.1 to 1.2) |
--Lifestyle | 91 | 0 (−1.4 to 1.7) | 99 |
−2 (−4.0 to −0.1)
*
|
--Wt loss, group | 41 | 0 (−2.0 to 2.3) | 46 | 1 (−1.6 to 3.6) |
--Wt loss, combination | 64 | 0 (−1.6 to 2.4) | 66 | −1 (−2.9 to 1.4) |