Stepping Up to Health: Feedback to Promote Physical Activity in Diabetes
|First Received Date ICMJE||September 6, 2005|
|Last Updated Date||December 8, 2009|
|Start Date ICMJE||June 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00151021 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Stepping Up to Health: Feedback to Promote Physical Activity in Diabetes|
|Official Title ICMJE||Automated Step-count Feedback to Promote Physical Activity in Diabetes|
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.
Objective #1: To develop and test a computer program that automatically collects enhanced pedometer data, records the data in a format suitable for statistical analysis, and generates a personally tailored motivational web page and distributes an e-mail reminder message to encourage the participant to log on to his/her website.
Objective #2: To compare total daily steps in people with diabetes randomized to two different 6-week pedometer and web-based walking interventions. The two interventions will differ only in the emphasis for goal setting and feedback.
Group 1: Emphasizes 10-minute minimum duration of physical activity bouts
Group 2: Emphasizes total daily steps without regard to duration of walking bouts
Objective #3: To compare steps accumulated in walking bouts lasting for at least 10 minutes between the same two groups of participants with diabetes.
Objective #4: To assess the feasibility, cost, dropout rate and participant satisfaction with a pedometer and web-based walking intervention for participants with diabetes.
This study will consist of three phases. Phase I will be the development of a web-based interactive system including data downloading and tailored messages.
Phase II is a usability testing phase in which 8 participants will be recruited to wear the pedometer, interact with the web-based system and give feedback for final development. The Usability phase will occur exactly like the Phase III outlined below except that the participants will be assigned to a study group rather than randomized, and they will be on-study for 2 weeks only - one week for the enrollment phase and one week of the intervention phase. At the end of the intervention week, they will not complete the post survey but will instead complete a feasibility/usability survey and meet with the study staff to help define improvements and adjustments for the Phase III trial. To maximize the Usability Phase, the feedback received from the first four participants will be incorporated in the website before the last four participants are enrolled.
The final phase (Phase III) will include a total of 40 men and women ages > 18 years old, who have Type II Diabetes and are interested in starting a walking program. If they meet eligibility and sign a consent form they will enroll in a randomized control trial comparing two similar interventions to promote walking. Both interventions are 6-week pedometer-based interventions that rely on step-count feedback to motivate participants to increase their walking. Tailored behavioral, informational and motivational messages will be delivered on the website and the enhanced pedometer work by participants will automatically upload time-stamped step count data to a central computer. One of the interventions, the "10 minute bouts" intervention will emphasize bouts of walking lasting at least 10 minutes and of at least moderate intensity. The second intervention called the "total steps" intervention will emphasize total accumulated daily step counts without regard to duration or intensity of walking bouts.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
|Condition ICMJE||Diabetes Mellitus, Type 2|
|Intervention ICMJE||Behavioral: Tailored web-based walking program|
|Study Arm (s)||Not Provided|
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||40|
|Completion Date||January 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00151021|
|Other Study ID Numbers ICMJE||MDRTC 5P60DKK20572|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Michigan|
|Collaborators ICMJE||Michigan Diabetes and Training Center|
|Information Provided By||University of Michigan|
|Verification Date||December 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP