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

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 3

Conditions

Hypertension
Menopause
Hypercholesterolemia
Diabetes Mellitus
Obesity
Cardiovascular Diseases
Postmenopause
Heart Diseases

Treatments

Behavioral: diet, fat-restricted

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000532
R01HL045167 (U.S. NIH Grant/Contract)
75

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

45 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Premenopausal women, ages 45-50 at entry.

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems