Women's Walking Program
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      African American (AA) women have the lowest physical activity (PA) levels, which contributes
      to substantial disparities in cardiovascular health and depressive symptoms. There is a need
      to examine ways to promote PA that are appealing, applicable to clinical practice, and
      cost-effective. The purpose of this clinical trial is to test the efficacy of the Women's
      Walking Program (WWP), consisting of a lifestyle PA prescription and "group visit" delivery
      model, with or without tailored telephone contacts between group visits for increasing
      adherence to PA and improving health outcomes. Two telephone contact strategies will be
      compared against a no-telephone control condition: a person-administered contact strategy
      using brief motivational interviewing and an automated contact strategy using a telephone
      computer-linked system. Group visits and telephone contacts are designed to increase
      adherence to lifestyle PA with an emphasis on accumulation of 3,000 steps daily over
      baseline. The aims of this study are (1) to compare the initial (adoption 24 weeks) and
      longer-term (maintenance 2nd 24 weeks) effectiveness of the WWP plus person-administered
      telephone contacts, WWP plus automated telephone contacts, and the WWP without telephone
      contacts on (a) increasing adherence to lifestyle PA, (b) improving health outcomes (aerobic
      fitness, body composition, depressive symptoms), (c) improving self-efficacy (confidence in
      one's ability to be physically active) and outcome expectations (expected benefits to being
      more active); and (2) to compare cost-effectiveness of the three telephone treatment
      conditions in relation to adherence to lifestyle PA and health outcomes.

      The investigators will randomly assignment of the order of administering the three conditions
      to six community health care sites. These six sites are similar with respect to race,
      socioeconomic status, and residential mobility. The study will include 288 sedentary AA women
      aged 40 to 65 years who have no major signs or symptoms of cardiovascular disease (CVD); no
      history of myocardial infarction, stroke, or diabetics with elevated HgA1c; BP < 160/100.

      Initial screening will occur in person or over the phone. Further screening at the data
      collection site with an advanced practice nurse will include blood work for glucose and
      lipoproteins, a history and physical, and resting EKG. At baseline, 24 and 48 weeks all women
      who are eligible will: be given questionnaires on physical activity, health and factors that
      influence their physical activity; have their height, weight, waist circumference measured;
      and do a two minute step test. All three treatment group will attend 5 group visits every 5
      weeks during adoption (first 24 weeks) and 1 booster group visit during maintenance (week
      36). The group visit consists of brief individual time with a staff member followed by a
      group visit with motivational videotapes. All treatment groups will self-monitor their
      physical activity with accelerometers and enter their step data into a voice response system.

      The groups receiving the automated telephone contact strategy and the group receiving the
      person telephone contact strategy will have the same number and spacing of the telephone
      contacts (nine 10- to 15-minute telephone contacts delivered every two to three weeks between
      group visits during adoption and two telephone contacts [weeks 28, 43] during maintenance).
      Using motivational interviewing, a nurse will tailor the telephone discussion to the person
      telephone contact group to match the participant's needs, experiences, barriers, motivation,
      and confidence. Women in the automated telephone contact group will receive an automated call
      with feedback on their progress based on the information they reported into the ATCL system.
      The automated telephone contact system will deliver feedback on progress, problem solving,
      goal-setting, and support. All information will be delivered in the voice of one of our staff
      members. The third treatment group will receive no telephone contacts between group visits.

      Potential risks exist for women who have medical problems, which contraindicate physical
      exercise. Additional risks associated with the walking program include safety and injury.
      There are potential risks of infection at the site of the one time finger blood withdrawal.
      Potential benefits to subjects include improved aerobic fitness, blood cholesterol, body
      composition and blood pressure and fewer symptoms. The subjects will be given a physical
      activity prescription that should benefit them through life and decrease their risk for CVD.

      Women will be recruited throughout the West and South side of Chicago. They will give verbal
      consent at the screening questionnaire and sign an informed consent at the time of the
      screening history and physical. They will be told that participation is voluntary, they may
      decline or withdraw at will at any time, and all results will be held strictly confidential.
    


Intervention name(s): Walking Program + Motivational Interviewing Calls; Walking Program + Automated Calls; Walking Program
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical Activity; African American; Adherence