NCT00151021

Brief Summary

The primary purpose of this study is to test an Internet based program along with an enhanced pedometer to promote walking in people with diabetes. The major research question to be answered is if counseling and feedback that emphasizes a 10-minute minimum duration for physical activity bouts result in a different pattern of walking behavior compared to counseling and feedback focusing only on total daily accumulated steps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2005

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 9, 2009

Status Verified

December 1, 2009

First QC Date

September 6, 2005

Last Update Submit

December 8, 2009

Conditions

Keywords

DiabetesPedometerBehavioral

Outcome Measures

Primary Outcomes (1)

  • Step-count bout ratio = 7 day average of steps taken during 10 minute bouts in one day divided by total steps taken during the same day

Interventions

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Have type 2 diabetes
  • Have a sedentary lifestyle
  • Interested in starting a walking program
  • Regular computer users who check e-mail at least 5 times a week and have access to a personal computer (PC) with XP or Windows 2000 operating system, 128 MB of memory, and an available universal serial bus (USB) port.
  • Can identify a primary care doctor, endocrinologist or cardiologist and obtain written clearance to start a walking program.
  • Willing to provide written informed consent
  • Can communicate in English

You may not qualify if:

  • Used a pedometer in past 30 days
  • Currently pregnant
  • Cannot comfortably walk at least one block
  • Cannot obtain written clearance to start a walking program from primary care doctor, endocrinologist or cardiologist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan, Department of Family Medicine

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • Richardson CR, Mehari KS, McIntyre LG, Janney AW, Fortlage LA, Sen A, Strecher VJ, Piette JD. A randomized trial comparing structured and lifestyle goals in an internet-mediated walking program for people with type 2 diabetes. Int J Behav Nutr Phys Act. 2007 Nov 16;4:59. doi: 10.1186/1479-5868-4-59.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusBehavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Caroline R Richardson, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

June 1, 2005

Study Completion

January 1, 2006

Last Updated

December 9, 2009

Record last verified: 2009-12

Locations