Enhancing Adherence by Building Online Communities - Full Text View

Purpose

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

Condition	Intervention	Phase
Type 2 Diabetes Coronary Artery Disease Obesity	Behavioral: Stepping Up to Health	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Diabetes Diabetes Type 2 Obesity

U.S. FDA Resources

Further study details as provided by Robert Wood Johnson Foundation:

Primary Outcome Measures:

Total steps [ Time Frame: last 30 days of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

dropout rate [ Time Frame: Four months ] [ Designated as safety issue: No ]
days and hours pedometer worn [ Time Frame: four months ] [ Designated as safety issue: No ]
login frequency [ Time Frame: four months ] [ Designated as safety issue: No ]
upload frequency [ Time Frame: four months ] [ Designated as safety issue: No ]
content of posts (qualitative) [ Time Frame: four months ] [ Designated as safety issue: No ]

Enrollment:	324
Study Start Date:	January 2008
Study Completion Date:	January 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Stepping Up to Health only	Behavioral: Stepping Up to Health Internet-mediated walking program with pedometers, goal-setting and tailored messaging
Experimental: 2 Stepping up to Health PLUS online message boards to talk with other participants	Behavioral: Stepping Up to Health Internet-mediated walking program with pedometers, goal-setting and tailored messaging

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729040

Sponsors and Collaborators

Robert Wood Johnson Foundation

Investigators

Principal Investigator:

Caroline R Richardson, MD

University of Michigan Health System Dept. of Family Medicine

More Information

No publications provided by Robert Wood Johnson Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

Responsible Party:	Caroline Richardson, MD, University of Michigan Health System Dept. of Family Medicine
ClinicalTrials.gov Identifier:	NCT00729040 History of Changes
Other Study ID Numbers:	57408
Study First Received:	August 1, 2008
Last Updated:	January 27, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Robert Wood Johnson Foundation:

heart
weight
Overweight
bmi
diabetes
type 2
diabetic
walk

walk*
diab*
obese
exercise
activity
coronary
pedometer

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013