- Koertge J.
- Weidner G.
- Elliott-Eller M.
- Scherwitz L.
- Merritt-Worden T.A.
- Marlin R.
- Lipsenthal L.
- Guarneri M.
- Finkel R.
- Saunders Jr, D.E.
- et al.
Methods
Design, recruitment, and procedure of the MLDP
- Koertge J.
- Weidner G.
- Elliott-Eller M.
- Scherwitz L.
- Merritt-Worden T.A.
- Marlin R.
- Lipsenthal L.
- Guarneri M.
- Finkel R.
- Saunders Jr, D.E.
- et al.
Subjects
- Koertge J.
- Weidner G.
- Elliott-Eller M.
- Scherwitz L.
- Merritt-Worden T.A.
- Marlin R.
- Lipsenthal L.
- Guarneri M.
- Finkel R.
- Saunders Jr, D.E.
- et al.
- Koertge J.
- Weidner G.
- Elliott-Eller M.
- Scherwitz L.
- Merritt-Worden T.A.
- Marlin R.
- Lipsenthal L.
- Guarneri M.
- Finkel R.
- Saunders Jr, D.E.
- et al.
Measurements
- Ware J.E.
- Gandek B.
- Kosinski M.
- Aaronson N.K.
- Apolone G.
- Brazier J.
- Bullinger M.
- Kaasa S.
- Leplège A.
- Prieto L.
- et al.
Intervention: the Lifestyle Change Program
- Koertge J.
- Weidner G.
- Elliott-Eller M.
- Scherwitz L.
- Merritt-Worden T.A.
- Marlin R.
- Lipsenthal L.
- Guarneri M.
- Finkel R.
- Saunders Jr, D.E.
- et al.
Adherence to the Lifestyle Change Program
Statistical analysis
Measurement | DM Status | Baseline | 3 Months | 12 Months | p Value | ||
---|---|---|---|---|---|---|---|
Time | DM Status | Gender | |||||
Body weight (kg) | Diabetic men | 95.3 ± 18.9 (43)a | 90.9 ± 16.7b | 89.9 ± 15.6b | <0.001 | <0.01 | <0.001 |
Nondiabetic men | 85.7 ± 15.8 (220)a | 81.3 ± 13.3b | 81.0 ± 13.1b | ||||
Diabetic women | 80.3 ± 17.4 (21)a | 76.4 ± 16.3b | 75.2 ± 15.5b | ||||
Nondiabetic women | 75.5 ± 17.7 (43)a | 70.6 ± 16.2b | 69.7 ± 16.3b | ||||
Body fat (%) | Diabetic men | 24.6 ± 6.8 (40)a | 21.9 ± 6.4b | 20.7 ± 6.3b | <0.001 | 0.158 | <0.001 |
Nondiabetic men | 22.3 ± 5.8 (195)a | 19.4 ± 5.0b | 18.8 ± 5.2b | ||||
Diabetic women | 35.4 ± 6.1 (17)a | 31.1 ± 7.5b | 30.4 ± 7.1b | ||||
Nondiabetic women | 34.9 ± 5.5 (37)a | 31.8 ± 5.6b | 30.5 ± 5.8b | ||||
Systolic blood pressure (mm Hg) | Diabetic men | 137 ± 19 (40)a | 132 ± 19a | 134 ± 21a | 0.795 | 0.131 | 0.735 |
Nondiabetic men | 131 ± 18 (165)a | 126 ± 18a | 128 ± 18a | ||||
Diabetic women | 132 ± 15 (18)a | 129 ± 16a | 132 ± 20a | ||||
Nondiabetic women | 136 ± 20 (33)a | 129 ± 19a | 134 ± 16a | ||||
Diastolic blood pressure (mm Hg) | Diabetic men | 80 ± 10 (40)a | 74 ± 9b | 75 ± 11b | <0.03 § Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline. | <0.02 § Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline. | 0.900 |
Nondiabetic men | 79 ± 10 (164)a | 74 ± 11b | 76 ± 10b | ||||
Diabetic women | 77 ± 11 (18)a | 72 ± 14b | 72 ± 10b | ||||
Nondiabetic women | 81 ± 8 (33)a | 77 ± 10b | 78 ± 11b | ||||
Heart rate at rest (beats/min) | Diabetic men | 73 ± 14 (38)a | 69 ± 13b | 72 ± 13a | <0.001 | <0.05 § Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline. | <0.01 |
Nondiabetic men | 68 ± 13 (178)a | 64 ± 11b | 67 ± 12a | ||||
Diabetic women | 77 ± 11 (19)a | 73 ± 14b | 77 ± 12a | ||||
Nondiabetic women | 76 ± 14 (33)a | 71 ± 14b | 73 ± 12a | ||||
Total serum cholesterol (mg/dl) | Diabetic men | 199 ± 55 (41)a | 177 ± 69b | 171 ± 37b | 0.052 | 0.704 | <0.01 |
Nondiabetic men | 195 ± 57 (207)a | 177 ± 55b | 180 ± 37b | ||||
Diabetic women | 210 ± 33 (20)a | 204 ± 43b | 192 ± 41b | ||||
Nondiabetic women | 222 ± 42 (40)a | 204 ± 39b | 204 ± 44b | ||||
Low-density lipoprotein cholesterol (mg/dl) | Diabetic men | 116 ± 37 (35)a | 97 ± 32b | 95 ± 27b | <0.01 | 0.401 | <0.05 § Adjustments for multiple medical outcomes rendered this finding nonsignificant. After adjusting for multiple medical outcomes, only 1 significant 2-way interaction remained that involved time and DM on heart rate at rest. Two additional significant 2-way interactions could be found: 1 2-way interaction involving gender and DM on mental health and 1 2-way interaction involving the effects of gender and time on dietary fat. These effects indicated lowest heart rates among patients without DM at 1 year and lowest mental health scores among women with DM. The highest fat intake was observed among women at baseline. |
Nondiabetic men | 121 ± 48 (193)a | 101 ± 41b | 105 ± 34b | ||||
Diabetic women | 125 ± 31 (19)a | 115 ± 35b | 101 ± 23b | ||||
Nondiabetic women | 135 ± 40 (39)a | 115 ± 39b | 116 ± 36b | ||||
High-density lipoprotein cholesterol (mg/dl) | Diabetic men | 35 ± 12 (38)a | 31 ± 9b | 34 ± 9a,b | 0.122 | 0.162 | <0.001 |
Nondiabetic men | 35 ± 10 (198)a | 31 ± 8b | 34 ± 9a,b | ||||
Diabetic women | 41 ± 10 (20)a | 38 ± 10b | 41 ± 12a,b | ||||
Nondiabetic women | 47 ± 13 (40)a | 43 ± 16b | 47 ± 15a,b | ||||
Triglycerides (mg/dl) | Diabetic men | 321 ± 488 (41)a | 277 ± 251a | 280 ± 359a | 0.804 | 0.177 | 0.409 |
Nondiabetic men | 213 ± 158 (204)a | 230 ± 166a | 222 ± 129a | ||||
Diabetic women | 240 ± 155 (20)a | 262 ± 151a | 248 ± 176a | ||||
Nondiabetic women | 202 ± 83 (40)a | 244 ± 173a | 208 ± 97a | ||||
Exercise capacity (METs; ml O2/min/kg) | Diabetic men | 8.8 ± 2.8 (37)a | 10.8 ± 2.7b | 10.8 ± 2.4b | <0.001 | <0.01 | <0.001 |
Nondiabetic men | 10.4 ± 2.9 (180)a | 11.9 ± 2.6b | 12.5 ± 2.8b | ||||
Diabetic women | 6.9 ± 2.1 (20)a | 8.4 ± 2.6b | 8.5 ± 2.8b | ||||
Nondiabetic women | 8.3 ± 2.8 (33)a | 9.0 ± 2.9b | 10.0 ± 3.0b | ||||
Diet (% calories from fat) | Diabetic men | 14.2 ± 7.8 (38)a | 6.5 ± 2.1b | 6.4 ± 2.8b | <0.001 | <0.04 | <0.001 |
Nondiabetic men | 12.6 ± 7.8 (172)a | 6.2 ± 2.3b | 6.2 ± 2.6b | ||||
Diabetic women | 19 ± 7.7 (20)a | 7.1 ± 2.1b | 8.9 ± 5.3b | ||||
Nondiabetic women | 15.9 ± 8.7 (33)a | 6.8 ± 2.5b | 7.1 ± 3.3b | ||||
Exercise (h/wk) | Diabetic men | 1.8 ± 1.7 (44)a | 4.0 ± 3.3b | 3.8 ± 2.5b | <0.001 | 0.500 | <0.001 |
Nondiabetic men | 2.4 ± 2.0 (217)a | 4.1 ± 2.1b | 3.6 ± 2.1b | ||||
Diabetic women | 1.1 ± 1.1 (28)a | 3.0 ± 1.3b | 2.8 ± 1.4b | ||||
Nondiabetic women | 1.6 ± 1.5 (46)a | 3.3 ± 1.5b | 3.0 ± 1.7b | ||||
Stress management (h/wk) | Diabetic men | 0.5 ± 1.3 (45)a | 5.5 ± 2.4b | 4.6 ± 2.6b | <0.001 | <0.02 | 0.317 |
Nondiabetic men | 0.5 ± 1.3 (218)a | 5.6 ± 2.5b | 4.8 ± 2.9b | ||||
Diabetic women | 0.3 ± 0.7 (28)a | 4.9 ± 2.7b | 3.5 ± 2.8b | ||||
Nondiabetic women | 0.6 ± 1.1 (46)a | 5.7 ± 2.2b | 5.1 ± 2.5b | ||||
Intervention group (% attendance) | Diabetic men | 0.93 ± 0.08 (51)a | 080 ± 0.19b | <0.001 | 0.570 | <0.03 | |
Nondiabetic men | 0.93 ± 0.10 (272)a | 0.78 ± 0.20b | |||||
Diabetic women | 0.89 ± 0.13 (33)a | 0.71 ± 0.21b | |||||
Nondiabetic women | 0.92 ± 0.10 (54)a | 0.76 ± 0.23b | |||||
MOS SF-36 | |||||||
Physical health | Diabetic men | 43.6 ± 8.6 (42)a | 48.2 ± 8.2b | 48.5 ± 7.7b | <0.001 | <0.01 | <0.02 |
Nondiabetic men | 48.6 ± 9.1 (211)a | 51.8 ± 7.5b | 52.9 ± 7.3b | ||||
Diabetic women | 41.7 ± 8.1 (23)a | 47.5 ± 7.3b | 46.8 ± 6.3b | ||||
Nondiabetic women | 43.3 ± 9.6 (43)a | 47.7 ± 8.8b | 50.6 ± 7.9b | ||||
Mental health | Diabetic men | 46.5 ± 12.1 (42)a | 50.3 ± 9.2b | 51.8 ± 10.1b | <0.001 | <0.01 | 0.053 |
Nondiabetic men | 48.4 ± 10.3 (211)a | 52.9 ± 8.8b | 52.1 ± 9.7b | ||||
Diabetic women | 40.0 ± 10.1 (23)a | 47.4 ± 10.5b | 46.2 ± 12.5b | ||||
Nondiabetic women | 47.5 ± 9.7 (43)a | 54.4 ± 8.9b | 52.0 ± 9.2b |
Results
Baseline characteristics
Variable | Diabetic Men (n = 55) | Nondiabetic Men (n = 286) | p Value | Diabetic Women (n = 36) | Nondiabetic Women (n = 57) | p Value |
---|---|---|---|---|---|---|
Age (yrs) | 59 ± 10 | 58 ± 11 | 0.54 | 58 ± 11 | 60 ± 10 | 0.19 |
Education (yrs) | 16 ± 3 | 16 ± 3 | 0.68 | 15 ± 3 | 15 ± 3 | 0.44 |
Married or cohabitating | 47 (85%) | 253 (88%) | 0.98 | 23 (64%) | 35 (61%) | 0.10 |
Employed outside the home | 33 (60%) | 202 (70%) | <0.05 | 11 (31%) | 31 (54%) | 0.06 |
Spousal participation | 30 (55%) | 138 (48%) | 0.07 | 8 (22%) | 15 (26%) | 0.87 |
Family history of CAD | 40 (73%) | 156 (54%) | 0.08 | 23 (66%) | 35 (61%) | 0.38 |
Previous cigarette smoker | 40 (73%) | 199 (69%) | 0.70 | 19 (53%) | 33 (58%) | 0.63 |
Systemic hypertension | 41 (75%) | 121 (42%) | <0.01 | 23 (64%) | 29 (51%) | 0.38 |
Hyperlipidemia † Hyperlipidemia was defined as a low-density lipoprotein cholesterol level >100 mg/dl, a high-density lipoprotein cholesterol level ≤35 mg/dl, or a triglyceride level ≥200 mg/dl (National Cholesterol Education Program guidelines, Adult Treatment Panel II for individuals with established coronary heart disease). | 36 (66%) | 170 (59%) | <0.01 | 24 (67%) | 42 (74%) | 0.70 |
Previous myocardial infarction | 24 (44%) | 157 (54%) | 0.36 | 17 (47%) | 37 (65%) | 0.09 |
Previous coronary angioplasty | 20 (36%) | 137 (47%) | 0.10 | 21 (58%) | 26 (46%) | 0.23 |
Previous coronary bypass | 31 (56%) | 139 (48%) | 0.52 | 14 (39%) | 17 (30%) | 0.37 |
Angina pectoris (during past 30 d) | 34 (63%) | 110 (38%) | <0.01 | 17 (47%) | 32 (56%) | 0.40 |
Medication | ||||||
Nitrates | 22 (40%) | 76 (26%) | <0.05 | 18 (50%) | 15 (26%) | <0.05 |
β Blockers | 23 (42%) | 145 (50%) | 0.19 | 20 (56%) | 25 (44%) | 0.27 |
Angiotensin-converting enzyme inhibitors | 21 (38%) | 49 (17%) | <0.01 | 10 (28%) | 11 (19%) | 0.34 |
Calcium antagonists | 35 (64%) | 124 (43%) | <0.05 | 23 (64%) | 37 (65%) | 0.92 |
Diuretics | 8 (15%) | 22 (8%) | 0.22 | 11 (31%) | 12 (21%) | 0.30 |
Antihypertensives | 5 (9%) | 13 (5%) | 0.35 | 1 (3%) | 1 (2%) | 0.74 |
Lipid-lowering therapy | 30 (55%) | 149 (51%) | 0.31 | 16 (44%) | 36 (63%) | 0.08 |
Variable | Diabetic Men (n = 55) | Nondiabetic Men (n = 286) | p Value | Diabetic Women (n = 36) | Nondiabetic Women (n = 57) | p Value |
---|---|---|---|---|---|---|
Systolic blood pressure (mm Hg) | 139 ± 21 | 130 ± 19 | <0.01 | 135 ± 19 | 135 ± 19 | 0.98 |
Diastolic blood pressure (mm Hg) | 81 ± 10 | 79 ± 10 | 0.33 | 77 ± 10 | 79 ± 10 | 0.34 |
Heart rate at rest (beats/min) | 73 ± 14 | 68 ± 12 | <0.05 | 78 ± 12 | 73 ± 14 | 0.09 |
Body mass index (kg/m2) | 30.5 ± 5.8 | 27.3 ± 5.2 | <0.01 | 30.7 ± 5.5 | 28.8 ± 7.1 | 0.19 |
Body weight (kg) | 92.8 ± 18.0 | 86.1 ± 15.6 | <0.01 | 81.6 ± 16.8 | 73.5 ± 16.8 | <0.05 |
Body fat (%) | 24.5 ± 7 | 22.8 ± 5.9 | 0.07 | 34.7 ± 6.3 | 34.2 ± 5.6 | 0.72 |
Total serum cholesterol (mg/dl) | 197 ± 52 | 195 ± 54 | 0.84 | 214 ± 41 | 226 ± 48 | 0.24 |
Low-density lipoprotein cholesterol (mg/dl) | 114 ± 38 | 119 ± 46 | 0.50 | 133 ± 36 | 138 ± 44 | 0.63 |
High-density lipoprotein cholesterol (mg/dl) | 35 ± 11 | 35 ± 10 | 0.94 | 43 ± 12 | 45 ± 12 | 0.50 |
Triglycerides (mg/dl) | 244 ± 142 | 216 ± 156 | 0.23 | 228 ± 140 | 217 ± 93 | 0.66 |
Exercise capacity (METs; ml O2/min/kg) | 8.7 ± 2.9 | 10.2 ± 2.9 | <0.01 | 6.7 ± 1.9 | 8.1 ± 2.4 | <0.01 |
Diet (% calories from fat) | 14.4 ± 8.3 | 12.9 ± 8.4 | 0.26 | 17.8 ± 7.8 | 16.4 ± 9.4 | 0.50 |
Exercise (h/wk) | 1.7 ± 1.7 | 2.4 ± 2.2 | <0.05 | 1 ± 1.1 | 1.7 ± 1.5 | <0.05 |
Stress management (h/wk) | 0.5 ± 1.3 | 0.5 ± 1.3 | 0.69 | 0.37 ± 0.78 | 0.83 ± 1.5 | 0.10 |
MOS SF-36: physical health | 43.1 ± 9.0 | 48.3 ± 8.9 | <0.01 | 39.4 ± 8.5 | 44.0 ± 9.5 | <0.05 |
MOS SF-36: mental health | 46.5 ± 11.4 | 48.1 ± 10.1 | 0.32 | 43.0 ± 10.3 | 47.7 ± 9.7 | <0.05 |
Changes | Baseline | 1 Year |
---|---|---|
No change: 62 (68.1%) | ||
16 (17.6%) | No medication, insulin levels controlled by diet | No medication, insulin levels controlled by diet |
25 (27.5%) | Insulin | Insulin |
21 (23.1%) | Oral antiglycemic | Oral antiglycemic |
Improvement: 18 (20%) | ||
1 | Insulin | Discontinued insulin without adopting another medical regimen |
6 | Insulin | Oral antiglycemic |
11 | Oral antiglycemic | Discontinued oral antiglycemic without adopting another regimen |
Worsening: 6 (6.6%) | ||
1 | Oral antiglycemic | Insulin |
1 | No medication | Insulin |
4 | No Medication | Oral antiglycemic |
Participant characteristics at follow-ups
Participants lost to follow-up
- Koertge J.
- Weidner G.
- Elliott-Eller M.
- Scherwitz L.
- Merritt-Worden T.A.
- Marlin R.
- Lipsenthal L.
- Guarneri M.
- Finkel R.
- Saunders Jr, D.E.
- et al.
Discussion
Centers for Medicare & Medicaid Services. Announcement of the implementation of the Medicare Lifestyle Modification Program Demonstration Project. Federal Register Notice. January 5, 2000. Available at: http://www.cms.hhs.gov/researchers/demos/preventiveservices/3q4.asp. Accessed July 5, 2005
Acknowledgment
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Article Info
Publication History
Footnotes
Preparation of this report was supported in part by the German Academic Exchange Service and the Alexander von Humboldt Foundation, Bonn, Germany.