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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-01

Study Completion Date

2009-11-01

Brief Summary

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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.

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Detailed Description

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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

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Healthy Obesity Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm I (health coach)

Participants participate in a 12-week physical activity intervention (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.

Group Type EXPERIMENTAL

communication intervention

Intervention Type BEHAVIORAL

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.

exercise intervention

Intervention Type BEHAVIORAL

Participants participate in a 12-week physical activity intervention administered using an IVR system.

Arm II (no coach condition)

Participants participate in a 12-week physical activity intervention (walking program)and receive health mail messages via IVR system. Participants in this arm of the study only interacted with the IVR system.

Group Type ACTIVE_COMPARATOR

exercise intervention

Intervention Type BEHAVIORAL

Participants participate in a 12-week physical activity intervention administered using an IVR system.

Interventions

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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.

Intervention Type BEHAVIORAL

exercise intervention

Participants participate in a 12-week physical activity intervention administered using an IVR system.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Electra Paskett

Associate Director for Population Sciences, Comprehensive Cancer Center, Ohio State University; Marion N. Rowley Professor of Cancer Research and Director, Division of Cancer Prevention and Control

Responsibility Role PRINCIPAL_INVESTIGATOR