Low-fat dietary pattern and risk of cardiovascular disease: The Women's Health Initiative randomized controlled dietary modification trial

Barbara V. Howard, Linda Van Horn, Judith Hsia, Jo Ann E. Manson, Marcia L. Stefanick, Sylvia Wassertheil-Smoller, Lewis H. Kuller, Andrea Z. LaCroix, Robert D. Langer, Norman L. Lasser, Cora E. Lewis, Marian C. Limacher, Karen L. Margolis, W. Jerry Mysiw, Judith K. Ockene, Linda M. Parker, Michael G. Perri, Lawrence Phillips, Ross L. Prentice, John RobbinsJacques E. Rossouw, Gloria E. Sarto, Irwin J. Schatz, Linda G. Snetselaar, Victor J. Stevens, Lesley F. Tinker, Maurizio Trevisan, Mara Z. Vitolins, Garnet L. Anderson, Annlouise R. Assaf, Tamsen Bassford, Shirley A.A. Beresford, Henry R. Black, Robert L. Brunner, Robert G. Brzyski, Bette Caan, Rowan T. Chlebowski, Margery Gass, Iris Granek, Philip Greenland, Jennifer Hays-Grudo, David Heber, Gerardo Heiss, Susan L. Hendrix, F. Allan Hubbell, Karen C. Johnson, Jane Morley Kotchen

Research output: Contribution to journalArticle

732 Citations (Scopus)

Abstract

Context: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed. Objective: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. Design, Setting, and Participants: Randomized controlled trial of 48 835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19 541 [40%]) or comparison group (29 294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years. Intervention: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/ fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials. Main Outcome Measures: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke). Results: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/ fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits. Conclusions: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.

Original languageEnglish
Pages (from-to)655-666
Number of pages12
JournalJournal of the American Medical Association
Volume295
Issue number6
DOIs
StatePublished - 8 Feb 2006

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Diet Therapy
Dietary Fats
Women's Health
Cardiovascular Diseases
Coronary Disease
Fats
Vegetables
Stroke
Fruit
Diet
Confidence Intervals
Blood Pressure
Behavior Therapy
Incidence
Energy Intake
LDL Cholesterol
HDL Cholesterol
Life Style
Epidemiologic Studies
Triglycerides

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Howard, B. V., Van Horn, L., Hsia, J., Manson, J. A. E., Stefanick, M. L., Wassertheil-Smoller, S., ... Kotchen, J. M. (2006). Low-fat dietary pattern and risk of cardiovascular disease: The Women's Health Initiative randomized controlled dietary modification trial. Journal of the American Medical Association, 295(6), 655-666. https://doi.org/10.1001/jama.295.6.655
Howard, Barbara V. ; Van Horn, Linda ; Hsia, Judith ; Manson, Jo Ann E. ; Stefanick, Marcia L. ; Wassertheil-Smoller, Sylvia ; Kuller, Lewis H. ; LaCroix, Andrea Z. ; Langer, Robert D. ; Lasser, Norman L. ; Lewis, Cora E. ; Limacher, Marian C. ; Margolis, Karen L. ; Mysiw, W. Jerry ; Ockene, Judith K. ; Parker, Linda M. ; Perri, Michael G. ; Phillips, Lawrence ; Prentice, Ross L. ; Robbins, John ; Rossouw, Jacques E. ; Sarto, Gloria E. ; Schatz, Irwin J. ; Snetselaar, Linda G. ; Stevens, Victor J. ; Tinker, Lesley F. ; Trevisan, Maurizio ; Vitolins, Mara Z. ; Anderson, Garnet L. ; Assaf, Annlouise R. ; Bassford, Tamsen ; Beresford, Shirley A.A. ; Black, Henry R. ; Brunner, Robert L. ; Brzyski, Robert G. ; Caan, Bette ; Chlebowski, Rowan T. ; Gass, Margery ; Granek, Iris ; Greenland, Philip ; Hays-Grudo, Jennifer ; Heber, David ; Heiss, Gerardo ; Hendrix, Susan L. ; Hubbell, F. Allan ; Johnson, Karen C. ; Kotchen, Jane Morley. / Low-fat dietary pattern and risk of cardiovascular disease : The Women's Health Initiative randomized controlled dietary modification trial. In: Journal of the American Medical Association. 2006 ; Vol. 295, No. 6. pp. 655-666.
@article{b47d6f3dd8664c5dae4eaaae8bfdd04c,
title = "Low-fat dietary pattern and risk of cardiovascular disease: The Women's Health Initiative randomized controlled dietary modification trial",
abstract = "Context: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed. Objective: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. Design, Setting, and Participants: Randomized controlled trial of 48 835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19 541 [40{\%}]) or comparison group (29 294 [60{\%}]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years. Intervention: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20{\%} of calories and increase intakes of vegetables/ fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials. Main Outcome Measures: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke). Results: By year 6, mean fat intake decreased by 8.2{\%} of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9{\%}), monounsaturated (3.3{\%}), and polyunsaturated (1.5{\%}) fat; increases occurred in intakes of vegetables/ fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29{\%}, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63{\%}), 434 (0.28{\%}), and 1357 (0.86{\%}) in the intervention and 1549 (0.65{\%}), 642 (0.27{\%}), and 2088 (0.88{\%}) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95{\%} confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95{\%} CI, 0.90-1.15), or CVD (HR, 0.98; 95{\%} CI, 0.92-1.05). Excluding participants with baseline CVD (3.4{\%}), the HRs (95{\%} CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits. Conclusions: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.",
author = "Howard, {Barbara V.} and {Van Horn}, Linda and Judith Hsia and Manson, {Jo Ann E.} and Stefanick, {Marcia L.} and Sylvia Wassertheil-Smoller and Kuller, {Lewis H.} and LaCroix, {Andrea Z.} and Langer, {Robert D.} and Lasser, {Norman L.} and Lewis, {Cora E.} and Limacher, {Marian C.} and Margolis, {Karen L.} and Mysiw, {W. Jerry} and Ockene, {Judith K.} and Parker, {Linda M.} and Perri, {Michael G.} and Lawrence Phillips and Prentice, {Ross L.} and John Robbins and Rossouw, {Jacques E.} and Sarto, {Gloria E.} and Schatz, {Irwin J.} and Snetselaar, {Linda G.} and Stevens, {Victor J.} and Tinker, {Lesley F.} and Maurizio Trevisan and Vitolins, {Mara Z.} and Anderson, {Garnet L.} and Assaf, {Annlouise R.} and Tamsen Bassford and Beresford, {Shirley A.A.} and Black, {Henry R.} and Brunner, {Robert L.} and Brzyski, {Robert G.} and Bette Caan and Chlebowski, {Rowan T.} and Margery Gass and Iris Granek and Philip Greenland and Jennifer Hays-Grudo and David Heber and Gerardo Heiss and Hendrix, {Susan L.} and Hubbell, {F. Allan} and Johnson, {Karen C.} and Kotchen, {Jane Morley}",
year = "2006",
month = "2",
day = "8",
doi = "10.1001/jama.295.6.655",
language = "English",
volume = "295",
pages = "655--666",
journal = "Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
number = "6",

}

Howard, BV, Van Horn, L, Hsia, J, Manson, JAE, Stefanick, ML, Wassertheil-Smoller, S, Kuller, LH, LaCroix, AZ, Langer, RD, Lasser, NL, Lewis, CE, Limacher, MC, Margolis, KL, Mysiw, WJ, Ockene, JK, Parker, LM, Perri, MG, Phillips, L, Prentice, RL, Robbins, J, Rossouw, JE, Sarto, GE, Schatz, IJ, Snetselaar, LG, Stevens, VJ, Tinker, LF, Trevisan, M, Vitolins, MZ, Anderson, GL, Assaf, AR, Bassford, T, Beresford, SAA, Black, HR, Brunner, RL, Brzyski, RG, Caan, B, Chlebowski, RT, Gass, M, Granek, I, Greenland, P, Hays-Grudo, J, Heber, D, Heiss, G, Hendrix, SL, Hubbell, FA, Johnson, KC & Kotchen, JM 2006, 'Low-fat dietary pattern and risk of cardiovascular disease: The Women's Health Initiative randomized controlled dietary modification trial', Journal of the American Medical Association, vol. 295, no. 6, pp. 655-666. https://doi.org/10.1001/jama.295.6.655

Low-fat dietary pattern and risk of cardiovascular disease : The Women's Health Initiative randomized controlled dietary modification trial. / Howard, Barbara V.; Van Horn, Linda; Hsia, Judith; Manson, Jo Ann E.; Stefanick, Marcia L.; Wassertheil-Smoller, Sylvia; Kuller, Lewis H.; LaCroix, Andrea Z.; Langer, Robert D.; Lasser, Norman L.; Lewis, Cora E.; Limacher, Marian C.; Margolis, Karen L.; Mysiw, W. Jerry; Ockene, Judith K.; Parker, Linda M.; Perri, Michael G.; Phillips, Lawrence; Prentice, Ross L.; Robbins, John; Rossouw, Jacques E.; Sarto, Gloria E.; Schatz, Irwin J.; Snetselaar, Linda G.; Stevens, Victor J.; Tinker, Lesley F.; Trevisan, Maurizio; Vitolins, Mara Z.; Anderson, Garnet L.; Assaf, Annlouise R.; Bassford, Tamsen; Beresford, Shirley A.A.; Black, Henry R.; Brunner, Robert L.; Brzyski, Robert G.; Caan, Bette; Chlebowski, Rowan T.; Gass, Margery; Granek, Iris; Greenland, Philip; Hays-Grudo, Jennifer; Heber, David; Heiss, Gerardo; Hendrix, Susan L.; Hubbell, F. Allan; Johnson, Karen C.; Kotchen, Jane Morley.

In: Journal of the American Medical Association, Vol. 295, No. 6, 08.02.2006, p. 655-666.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Low-fat dietary pattern and risk of cardiovascular disease

T2 - The Women's Health Initiative randomized controlled dietary modification trial

AU - Howard, Barbara V.

AU - Van Horn, Linda

AU - Hsia, Judith

AU - Manson, Jo Ann E.

AU - Stefanick, Marcia L.

AU - Wassertheil-Smoller, Sylvia

AU - Kuller, Lewis H.

AU - LaCroix, Andrea Z.

AU - Langer, Robert D.

AU - Lasser, Norman L.

AU - Lewis, Cora E.

AU - Limacher, Marian C.

AU - Margolis, Karen L.

AU - Mysiw, W. Jerry

AU - Ockene, Judith K.

AU - Parker, Linda M.

AU - Perri, Michael G.

AU - Phillips, Lawrence

AU - Prentice, Ross L.

AU - Robbins, John

AU - Rossouw, Jacques E.

AU - Sarto, Gloria E.

AU - Schatz, Irwin J.

AU - Snetselaar, Linda G.

AU - Stevens, Victor J.

AU - Tinker, Lesley F.

AU - Trevisan, Maurizio

AU - Vitolins, Mara Z.

AU - Anderson, Garnet L.

AU - Assaf, Annlouise R.

AU - Bassford, Tamsen

AU - Beresford, Shirley A.A.

AU - Black, Henry R.

AU - Brunner, Robert L.

AU - Brzyski, Robert G.

AU - Caan, Bette

AU - Chlebowski, Rowan T.

AU - Gass, Margery

AU - Granek, Iris

AU - Greenland, Philip

AU - Hays-Grudo, Jennifer

AU - Heber, David

AU - Heiss, Gerardo

AU - Hendrix, Susan L.

AU - Hubbell, F. Allan

AU - Johnson, Karen C.

AU - Kotchen, Jane Morley

PY - 2006/2/8

Y1 - 2006/2/8

N2 - Context: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed. Objective: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. Design, Setting, and Participants: Randomized controlled trial of 48 835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19 541 [40%]) or comparison group (29 294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years. Intervention: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/ fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials. Main Outcome Measures: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke). Results: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/ fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits. Conclusions: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.

AB - Context: Multiple epidemiologic studies and some trials have linked diet with cardiovascular disease (CVD) prevention, but long-term intervention data are needed. Objective: To test the hypothesis that a dietary intervention, intended to be low in fat and high in vegetables, fruits, and grains to reduce cancer, would reduce CVD risk. Design, Setting, and Participants: Randomized controlled trial of 48 835 postmenopausal women aged 50 to 79 years, of diverse backgrounds and ethnicities, who participated in the Women's Health Initiative Dietary Modification Trial. Women were randomly assigned to an intervention (19 541 [40%]) or comparison group (29 294 [60%]) in a free-living setting. Study enrollment occurred between 1993 and 1998 in 40 US clinical centers; mean follow-up in this analysis was 8.1 years. Intervention: Intensive behavior modification in group and individual sessions designed to reduce total fat intake to 20% of calories and increase intakes of vegetables/ fruits to 5 servings/d and grains to at least 6 servings/d. The comparison group received diet-related education materials. Main Outcome Measures: Fatal and nonfatal coronary heart disease (CHD), fatal and nonfatal stroke, and CVD (composite of CHD and stroke). Results: By year 6, mean fat intake decreased by 8.2% of energy intake in the intervention vs the comparison group, with small decreases in saturated (2.9%), monounsaturated (3.3%), and polyunsaturated (1.5%) fat; increases occurred in intakes of vegetables/ fruits (1.1 servings/d) and grains (0.5 serving/d). Low-density lipoprotein cholesterol levels, diastolic blood pressure, and factor VIIc levels were significantly reduced by 3.55 mg/dL, 0.31 mm Hg, and 4.29%, respectively; levels of high-density lipoprotein cholesterol, triglycerides, glucose, and insulin did not significantly differ in the intervention vs comparison groups. The numbers who developed CHD, stroke, and CVD (annualized incidence rates) were 1000 (0.63%), 434 (0.28%), and 1357 (0.86%) in the intervention and 1549 (0.65%), 642 (0.27%), and 2088 (0.88%) in the comparison group. The diet had no significant effects on incidence of CHD (hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.90-1.06), stroke (HR, 1.02; 95% CI, 0.90-1.15), or CVD (HR, 0.98; 95% CI, 0.92-1.05). Excluding participants with baseline CVD (3.4%), the HRs (95% CIs) for CHD and stroke were 0.94 (0.86-1.02) and 1.02 (0.90-1.17), respectively. Trends toward greater reductions in CHD risk were observed in those with lower intakes of saturated fat or trans fat or higher intakes of vegetables/fruits. Conclusions: Over a mean of 8.1 years, a dietary intervention that reduced total fat intake and increased intakes of vegetables, fruits, and grains did not significantly reduce the risk of CHD, stroke, or CVD in postmenopausal women and achieved only modest effects on CVD risk factors, suggesting that more focused diet and lifestyle interventions may be needed to improve risk factors and reduce CVD risk.

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DO - 10.1001/jama.295.6.655

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