NCT01940016

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

A Feasibility Study on the Effects of Tailored Communication and Health Coach Support on Physical Activity in Overweight Postmenopausal Women: BePHIT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Obesity
• Postmenopausal

Interventions

Type	Name	Description
BEHAVIORAL	communication intervention	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.
BEHAVIORAL	exercise intervention	Participants participate in a 12-week physical activity intervention administered using an IVR system.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2013-09-11
• Last updated: 2020-06-30

Locations

1 site across 1 country: United States