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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000532
First Posted: October 28, 1999
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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.

Condition Intervention Phase
Cardiovascular Diseases Diabetes Mellitus Heart Diseases Hypercholesterolemia Hypertension Obesity Menopause Postmenopause Behavioral: diet, fat-restricted Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 1992
Study Completion Date: January 2000
Detailed Description:

BACKGROUND:

Coronary heart disease causes almost as many deaths in women as it does in men, with approximately 90 percent of the deaths in women occurring after the age of 50. There are substantial increases in coronary heart disease risk factors at the time of the menopause, especially increases in total cholesterol and low density lipoprotein cholesterol, that may well contribute to the increased risk of coronary heart disease.

DESIGN NARRATIVE:

A total of 275 premenopausal women were randomized to a control group and 260 women into a lifestyle intervention group, a cognitive-behavioral program which was designed to reduce total dietary fat to less than 25 percent of calories, saturated fat to less than 7 percent of calories, and cholesterol to less than 100 mg. All women were given a weight loss goal of five to 15 pounds, depending on baseline weight status and asked to reduce calorie intake to 1300 kcal until weight goal was achieved. The intervention included an intensive group program during the first six months and follow-up individual/group sessions from six through 54 months. The primary endpoints of the trial were difference in the change in LDL cholesterol and weight between intervention and assessment-only groups at the end of the trial. The intervention also compared whether the dietary intervention could prevent the increase in low density lipoprotein cholesterol and the weight gain observed at this period of a woman's life; whether dietary intervention affected the age of menopause or the percent of women using hormone therapy or having hysterectomy; and whether the dietary intervention had adverse effects on menopausal symptomatology, endogenous hormones, and bone mineral density.

The Office of Research on Women's Health provided supplemental funds to measure hemostatic factors, including fibrinogen, factor VIIc and antigen, antithrombin III and PAI-1 in plasma samples for all subjects at baseline. The supplement allowed a longitudinal description of changes in hemostatic factors that appeared to occur during the perimenopausal transition and an investigation of whether diet and diet intervention altered the pattern of hemostatic changes observed at menopause.

Beginning in February 1996, the trial was extended for four years through January 2000 to provide for data analysis and an additional follow-up of at least 4.5 years for all participants.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
Premenopausal women, ages 45-50 at entry.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00000532     History of Changes
Other Study ID Numbers: 75
R01HL045167 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: May 13, 2016
Last Verified: April 2002

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders