Women's Walking Program



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:March 2010
End Date:November 2013
Contact:Diana Ingram, PhD
Email:Diana_Ingram@rush.edu
Phone:(312)942-9268

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Reducing Health Disparities in African American Women: Lifestyle Physical Activity Adherence


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.


Inclusion Criteria:

- AA female

- sedentary: Sedentary will be defined as no participation in regular planned (3 or
more times a week) moderate (e.g., walking) or vigorous (e.g., jogging, speed
walking) in the past 6 months.

- aged 40 to 65 years

- able to commit to attending the study group visits and have a telephone

- without disabilities that would prevent regular participation in PA such as walking
as determined by the PARQ and baseline screening. PA

Exclusion Criteria:

- Women will be excluded from the study if they have major signs or symptoms of CV
disease

- a history of myocardial infarction, stroke or Type 1 diabetes

- BP >160/100

- HgA1 >9 ( done on diabetics only)
We found this trial at
7
sites
Oak Park, Illinois 60304
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Chicago, Illinois 60629
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Chicago, Illinois 60628
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Chicago, Illinois 60651
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Chicago, IL
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