Communication & Peer Support Effects on Physical Activity in Overweight Postmenopausal Women

PRIMARY OBJECTIVES:

I. To design, develop and test the feasibility of implementing a physical activity
intervention using tailored communication and Interactive Voice Response (IVR) technology. We
will to address four basic questions to accomplish this aim:

1. Among overweight, postmenopausal women, who pass the screening criteria, what is the
percentage of women who are willing to participate in a 12-week physical activity
intervention that includes two 1-mile walk tests and two visits to the General Clinical
Research Center (GCRC)?

2. After beginning the study, what proportion of women use the cell phone and land line at
least 5 days a week to get a physical activity intervention message?

3. How many participants are enrolled and participating in the study at the end of the
12-week intervention period?

4. On average, how many steps per day do participants walk? How many of the participants
reach the 10,000 steps-per-day target by the end of the 12 week-intervention?

SECONDARY OBJECTIVES:

I. The effectiveness (satisfaction, convenience, ease of operation) of all the materials and
processes.

II. Examine whether social support from a health coach results in improvements in our
measures of adherence and satisfaction.

III. Examine the correlation between self-reported steps per day with improvements in
performance on a 1-mile walk test administered at the beginning and the end of the 12-week
intervention.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I. COACH-CONDITION: Participants participate in a 12-week physical activity program
(walking program)and receive health mail messages via IVR system and from a health coach.
Participants in this arm of the study, interacted with the IVR system and had the option of
interacting with the health coach.

ARM II: NO-COACH CONDITION: Participants participate in a 12-week physical activity program
(walking program) administered using an IVR system.

Inclusion Criteria:

- Present a letter/documentation from a primary physician stating that they can
participate in a physical activity program that will require walking up to 10,000
steps per day

- Have a body mass index (BMI) between 25 and 40 kg/m^2 (inclusive)

- Be postmenopausal, defined as no period for 12 months if over age 55, or no period for
12 months; also, women who have had their ovaries removed will be considered as
postmenopausal

- Willing to participate in a wellness program that lasts 12 weeks and involves walking
for at least 30 minutes a day on most days

- Has access to a cell phone during the 12-week intervention

- Functional knowledge of English (ability to both read and write)

Exclusion Criteria:

- Taking hormone replacement therapy within 3 months of enrollment

- Taking Tamoxifen or Raloxifene within 3 months of enrollment

- Enrolled in a weight management program, such as Weight Watchers

- Engaged in regular, planned walking of at least 30 minutes a day

- Previous history of breast cancer

- Premenopausal

- Age > 75 years, to minimize co-morbidities

- Cannot walk one mile