Communication & Peer Support Effects on Physical Activity in Overweight Postmenopausal Women
Condition: Healthy; Obesity; Postmenopausal
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This randomized clinical trial studies the feasibility of tailored physical activity
      intervention that is administered using Interactive Voice Response technology and cell
      phones. Interactive voice response and health coach support may motivate overweight
      postmenopausal women to stick to their exercise regimen to reduce the risk of getting breast
      cancer.
    

Detailed description: 
      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.
    

Intervention name(s): communication intervention; exercise intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants participate in a 12-week physical activity intervention (walking program)and receive health mail messages via IVR system and had the option of communicating with a health coach.; Participants participate in a 12-week physical activity intervention administered using an IVR system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Feasibility study; Interactive voice response system (IVR); health coach; no evidence of disease