Effect of a Low-Calorie Diet and/or Exercise Program on Risk Factors for Developing Breast Cancer in Overweight or Obese Postmenopausal Women
Condition: Breast Cancer; Obesity; Weight Changes
MeSH terms: Breast Neoplasms; Body Weight Changes
Study type: Interventional

Summary: 
      RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese
      postmenopausal woman's risk of developing breast cancer. It is not yet known whether a
      low-calorie diet and/or exercise program are more effective than no diet or exercise program
      in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.

      PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or
      exercise program on risk factors for developing breast cancer compared with no diet or
      exercise program in overweight or obese postmenopausal women.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the effects of a 1-year exercise intervention, reduced-calorie diet
           intervention, or a combined exercise and reduced-calorie diet intervention vs no
           intervention on serum estrone concentrations in overweight or obese postmenopausal
           women.

      Secondary

        -  Compare the effects of these interventions on serum levels of estradiol and free
           estradiol in these participants.

        -  Compare the effects of these interventions on serum levels of testosterone and free
           testosterone in these participants.

        -  Compare the effects of these interventions on serum levels of sex hormone binding
           globulin in these participants.

        -  Compare the effects of these interventions on serum levels of insulin in these
           participants.

        -  Compare the effects of these interventions on serum levels of glucose in these
           participants.

        -  Compare the effects of these interventions on serum levels of c-peptide in these
           participants.

        -  Compare the effects of these interventions on serum levels of insulin-like growth factor
           I (IGF-1) in these participants.

        -  Compare the effects of these interventions on serum levels of insulin-like growth factor
           binding-protein-3 (IGFBP-3) in these participants.

        -  Compare the effects of these interventions on serum levels of c-reactive protein (CRP)
           in these participants.

        -  Compare the effects of these interventions on serum levels of serum amyloid protein A
           (SAA) in these participants.

        -  Compare the effects of these interventions on serum levels of interleukin-6 (IL-6) in
           these participants.

        -  Compare the effects of these interventions on serum levels of adiponectin in these
           participants.

        -  Compare the effects of these interventions on serum levels of leptin in these
           participants.

        -  Compare the effects of these interventions on serum levels of ghrelin in these
           participants.

        -  Compare the effects of these interventions on serum levels of Vitamin D in these
           participants.

        -  Compare the effects of these interventions on mammographic density in these
           participants.

        -  Compare the effects of these interventions on anthropometrics and body composition
           (i.e., weight, body mass index, total and percentage body fat, and waist and hip
           circumferences) in these participants.

        -  Compare the effects of these interventions on quality of life in these participants.

        -  Compare the effects of these interventions on numbers of leukocytes and neutrophiles in
           these participants.

        -  Compare the effects of these interventions on VO2max in these participants.

      OUTLINE: This is a randomized study. Participants are stratified according to body mass index
      (< 30 vs ≥ 30). Participants are randomized to 1 of 4 intervention arms.

        -  Arm I (exercise program): Participants exercise 3 days per week under the supervision of
           a physiologist and 2 days per week independently at home, for a total of 5 exercise
           sessions (at least 45 minutes of moderate-intensity exercise per session) weekly over 12
           months.

        -  Arm II (reduced-calorie diet): Participants meet with a nutritionist individually and in
           small groups. Participants receive general information about diet and behavior
           strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and
           relapse-prevention training. Participants learn to set a calorie goal and a fat gram
           goal and how to achieve the goal calorie reduction. Meetings are held weekly during the
           first 6 months of the diet program but taper off over the course of the study.

        -  Arm III (exercise program and reduced-calorie diet): Participants meet with a
           physiologist and a nutritionist, as in arms I and II, and exercise and diet accordingly.

        -  Arm IV (control: delayed diet and exercise): Participants receive study materials on
           healthy diet and exercise at the end of the 12-month study period. In addition,
           participants are offered 2 months of group exercise training with a study physiologist
           and 4 group meetings with a nutritionist to learn about weight loss techniques and
           behavioral principles for achieving weight loss.

      All participants undergo testing at baseline and periodically during study. Participants
      undergo blood collection for evaluation of serum levels of sex and metabolic hormones (e.g.,
      estrone, estradiol, testosterone, free testosterone, and sex hormone binding globulin,
      radioimmunoassay and other immunoassays. Participants also undergo anthropometrics and body
      composition measurements and mammographic density assessment.

      Participants complete questionnaires at baseline and at 6 and 12 months for assessment of
      diet and exercise. Quality of life (QOL) is measured at baseline and at 6 and 12 months using
      the Medical Outcomes Study 36-Item Short Form and the Impact of Weight on QOL questionnaire.
      Information on health habits, medical history, family history of breast cancer, and
      reproductive and menstrual history is also collected.

      FINAL ACCRUAL: A total of 439 participants (118 in the caloric restriction arm, and 117 in
      both the CR+Exercise, and exercise only arm; and 87 in control arm) were accrued for this
      study.
    

Intervention name(s): behavioral dietary intervention; Exercise intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A group based modification of the DPP and LookAHEAD lifestyle programs with a goal of 10% weight loss; Facility based and home-based exercise designed to increase moderate-to-vigorous aerobic activity in participants to 45 mins/day 5 days/week
Other intervention name(s): Weight Loss interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: breast cancer; obesity; weight changes