Clinical trial NCT01940016: Communication & Peer Support Effects on Physical Activity in Overweight Postmenopausal Women
Official title: A Feasibility Study on the Effects of Tailored Communication and Health Coach Support on Physical Activity in Overweight Postmenopausal Women: BePHIT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Obesity
Postmenopausal
Keywords: Feasibility study
Interactive voice response system (IVR)
health coach
no evidence of disease
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2013-09-11
Enrollment: 71
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in time taken to complete a one mile walk.
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in anthropometrics, psychometrics and the benefits of a health coach.
timeFrame: 12 weeks
measure: Weekly effectiveness (satisfaction, convenience, ease of operation) of all the materials and processes as assessed by questionnaires.
timeFrame: 12 weeks
measure: If the self-reported steps per day, derived from daily activity logs, relates to the change in performance on the 1-mile walk test between baseline and end of study.
timeFrame: 12 Week
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Electra Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References: