Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause

NCT00000532 | Completed Phase 3

• 2 other identifiers: 75R01HL045167
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine if the increase in low density lipoprotein (LDL) cholesterol at the time of menopause could be ameliorated or prevented by an intensive dietary intervention. Also, to prevent the increase in body weight and associated changes in insulin, glucose, blood pressure, triglycerides, and high density lipoprotein cholesterol during the peri- to postmenopausal period.

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Heart Diseases; Hypercholesterolemia; Hypertension; Obesity; Menopause; Postmenopause

Interventions

diet, fat-restricted BEHAVIORAL

Eligibility Criteria

• Age: 45 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Premenopausal women, ages 45-50 at entry.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (15)

• Salamone LM, Ferrell R, Black DM, Palermo L, Epstein RS, Petro N, Steadman N, Kuller LH, Cauley JA. The association between vitamin D receptor gene polymorphisms and bone mineral density at the spine, hip and whole-body in premenopausal women. Osteoporos Int. 1996;6(1):63-8. doi: 10.1007/BF01626540.

  PMID: 8845602 BACKGROUND

• Simkin-Silverman L, Wing RR, Hansen DH, Klem ML, Pasagian-Macaulay AP, Meilahn EN, Kuller LH. Prevention of cardiovascular risk factor elevations in healthy premenopausal women. Prev Med. 1995 Sep;24(5):509-17. doi: 10.1006/pmed.1995.1081.

  PMID: 8524727 BACKGROUND

• Salamone LM, Gregg E, Wolf RL, Epstein RS, Black D, Palermo L, Kuller LH, Cauley JA. Are menopausal symptoms associated with bone mineral density and changes in bone mineral density in premenopausal women? Maturitas. 1998 Jun 3;29(2):179-87. doi: 10.1016/s0378-5122(98)00019-x.

  PMID: 9651908 BACKGROUND

• Sutton-Tyrrell K, Lassila HC, Meilahn E, Bunker C, Matthews KA, Kuller LH. Carotid atherosclerosis in premenopausal and postmenopausal women and its association with risk factors measured after menopause. Stroke. 1998 Jun;29(6):1116-21. doi: 10.1161/01.str.29.6.1116.

  PMID: 9626281 BACKGROUND

• Moriarty M, Wing RR, Kuller LH, Ferrell RE. Trp64Arg substitution in the beta 3-adrenergic receptor does not relate to body weight in healthy, premenopausal women. Int J Obes Relat Metab Disord. 1997 Sep;21(9):826-9. doi: 10.1038/sj.ijo.0800489.

  PMID: 9376898 BACKGROUND

• Salamone LM, Glynn NW, Black DM, Ferrell RE, Palermo L, Epstein RS, Kuller LH, Cauley JA. Determinants of premenopausal bone mineral density: the interplay of genetic and lifestyle factors. J Bone Miner Res. 1996 Oct;11(10):1557-65. doi: 10.1002/jbmr.5650111024.

  PMID: 8889857 BACKGROUND

• Wing RR. Changing diet and exercise behaviors in individuals at risk for weight gain. Obes Res. 1995 Sep;3 Suppl 2:277s-282s. doi: 10.1002/j.1550-8528.1995.tb00474.x.

  PMID: 8581787 BACKGROUND

• Simkin-Silverman LR, Wing RR, Boraz MA, Meilahn EN, Kuller LH. Maintenance of cardiovascular risk factor changes among middle-aged women in a lifestyle intervention trial. Womens Health. 1998 Fall;4(3):255-71.

  PMID: 9787651 BACKGROUND

• Salamone LM, Cauley JA, Zmuda J, Pasagian-Macaulay A, Epstein RS, Ferrell RE, Black DM, Kuller LH. Apolipoprotein E gene polymorphism and bone loss: estrogen status modifies the influence of apolipoprotein E on bone loss. J Bone Miner Res. 2000 Feb;15(2):308-14. doi: 10.1359/jbmr.2000.15.2.308.

  PMID: 10703933 BACKGROUND

• Salamone LM, Whiteside T, Friberg D, Epstein RS, Kuller LH, Cauley JA. Cytokine production and bone mineral density at the lumbar spine and femoral neck in premenopausal women. Calcif Tissue Int. 1998 Dec;63(6):466-70. doi: 10.1007/s002239900559.

  PMID: 9817939 BACKGROUND

• Kuller LH, Simkin-Silverman LR, Wing RR, Meilahn EN, Ives DG. Women's Healthy Lifestyle Project: A randomized clinical trial: results at 54 months. Circulation. 2001 Jan 2;103(1):32-7. doi: 10.1161/01.cir.103.1.32.

  PMID: 11136682 BACKGROUND

• Boraz MA, Simkin-Silverman LR, Wing RR, Meilahn EN, Kuller LH. Hormone replacement therapy use and menopausal symptoms among women participating in a behavioral lifestyle intervention. Prev Med. 2001 Aug;33(2 Pt 1):108-14. doi: 10.1006/pmed.2001.0858.

  PMID: 11493043 BACKGROUND

• Gregg EW, Kriska AM, Salamone LM, Wolf RL, Roberts MM, Ferrell RE, Anderson SJ, Kuller LH, Cauley JA. Correlates of quantitative ultrasound in the Women's Healthy Lifestyle Project. Osteoporos Int. 1999;10(5):416-24. doi: 10.1007/s001980050248.

  PMID: 10591840 BACKGROUND

• Salamone LM, Glynn N, Black D, Epstein RS, Palermo L, Meilahn E, Kuller LH, Cauley JA. Body composition and bone mineral density in premenopausal and early perimenopausal women. J Bone Miner Res. 1995 Nov;10(11):1762-8. doi: 10.1002/jbmr.5650101120.

  PMID: 8592954 BACKGROUND

• Salamone LM, Cauley JA, Black DM, Simkin-Silverman L, Lang W, Gregg E, Palermo L, Epstein RS, Kuller LH, Wing R. Effect of a lifestyle intervention on bone mineral density in premenopausal women: a randomized trial. Am J Clin Nutr. 1999 Jul;70(1):97-103. doi: 10.1093/ajcn/70.1.97.

  PMID: 10393145 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Heart Diseases; Hypercholesterolemia; Hypertension; Obesity

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Vascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: February 1, 1992
• Study Completion: January 1, 2000
• Last Updated: May 13, 2016

Record last verified: 2002-04