Women's Healthy Lifestyle Project: Cardiovascular Risk Factors and Menopause
Condition: Cardiovascular Diseases; Diabetes Mellitus; Heart Diseases; Hypercholesterolemia; Hypertension; Obesity; Menopause; Postmenopause
MeSH terms: Cardiovascular Diseases; Heart Diseases; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): diet, fat-restricted
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Prevention