NCT00729040

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Jan 2008

Typical duration for phase_1 type-2-diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

Enrollment Period

9 months

First QC Date

August 1, 2008

Last Update Submit

January 27, 2009

Conditions

Keywords

heartweightOverweightbmidiabetestype 2diabeticwalkwalk*diab*obeseexerciseactivitycoronarypedometer

Outcome Measures

Primary Outcomes (1)

  • Total steps

    last 30 days of intervention

Secondary Outcomes (5)

  • dropout rate

    Four months

  • days and hours pedometer worn

    four months

  • login frequency

    four months

  • upload frequency

    four months

  • content of posts (qualitative)

    four months

Study Arms (2)

1

ACTIVE COMPARATOR

Stepping Up to Health only

Behavioral: Stepping Up to Health

2

EXPERIMENTAL

Stepping up to Health PLUS online message boards to talk with other participants

Behavioral: Stepping Up to Health

Interventions

Internet-mediated walking program with pedometers, goal-setting and tailored messaging

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Coronary Artery DiseaseObesityBody WeightOverweightDiabetes MellitusMotor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesOvernutritionNutrition DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Caroline R Richardson, MD

    University of Michigan Health System Dept. of Family Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2008

First Posted

August 6, 2008

Study Start

January 1, 2008

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

January 29, 2009

Record last verified: 2009-01