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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00729040
Other study ID # 57408
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received August 1, 2008
Last updated January 27, 2009
Start date January 2008
Est. completion date January 2009

Study information

Verified date January 2009
Source Robert Wood Johnson Foundation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether online peer support will increase adherence to an internet-based pedometer walking program.


Description:

Stepping Up to Health with eCommunities is a study that takes what we already know about motivating sedentary, chronically ill people to walk, and begins to explore what it takes to keep people motivated to exercise over time: the ability to self-monitor behavior with accurate ecological momentary assessments.

We have theorized that peer support, monitoring and competition are ways in which people can stay motivated to meet their walking goals; thus, we have built into this intervention online forums for participants to communicate with each other and garner support, as well as a pilot one-to-many competitive game based on the percent of an individual's goal met.

Our research question is whether online community participation can increase adherence to an Internet-mediated walking program, which consists of an uploading pedometer, and going to a website to receive graphical and textual feedback as to whether participants are meeting gradually increasing walking goals. Three hundred participants will spend four months in this randomized, controlled trial to compare the intervention alone to the intervention plus online community support.


Recruitment information / eligibility

Status Completed
Enrollment 324
Est. completion date January 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes

- Must be sedentary, defined by less than 150 minutes of self-reported activity per week

- Must be 18 or older

- Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista

- Must be a regular email user (checking weekly)

- Must be able to communicate in English

Exclusion Criteria:

- Pregnant

- Cannot walk a block (self-report)

- Not competent to sign consent

- Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist)

- Type 1 diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Stepping Up to Health
Internet-mediated walking program with pedometers, goal-setting and tailored messaging

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Robert Wood Johnson Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary Total steps last 30 days of intervention No
Secondary dropout rate Four months No
Secondary days and hours pedometer worn four months No
Secondary login frequency four months No
Secondary upload frequency four months No
Secondary content of posts (qualitative) four months No
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