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:

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