Clinical trial NCT00729040: Enhancing Adherence by Building Online Communities
Official title: Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Coronary Artery Disease
Obesity
Keywords: heart
weight
Overweight
bmi
diabetes
type 2
diabetic
walk
walk*
diab*
obese
exercise
activity
coronary
pedometer
Lead sponsor: Robert Wood Johnson Foundation
Sponsor class: OTHER
First posted: 2008-08-06
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total steps
timeFrame: last 30 days of intervention
Secondary outcomes:
measure: dropout rate
timeFrame: Four months
measure: days and hours pedometer worn
timeFrame: four months
measure: login frequency
timeFrame: four months
measure: upload frequency
timeFrame: four months
measure: content of posts (qualitative)
timeFrame: four months
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan Health System Dept. of Family Medicine
name: Caroline R Richardson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Richardson CR, Buis LR, Janney AW, Goodrich DE, Sen A, Hess ML, Mehari KS, Fortlage LA, Resnick PJ, Zikmund-Fisher BJ, Strecher VJ, Piette JD. An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial. J Med Internet Res. 2010 Dec 17;12(4):e71. doi: 10.2196/jmir.1338.
citation: Buis LR, Janney AW, Hess ML, Culver SA, Richardson CR. Barriers encountered during enrollment in an internet-mediated randomized controlled trial. Trials. 2009 Aug 23;10:76. doi: 10.1186/1745-6215-10-76.