Stepping Up to Health: Feedback to Promote Physical Activity in Diabetes
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|ClinicalTrials.gov Identifier: NCT00151021|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Tailored web-based walking program||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Automated Step-count Feedback to Promote Physical Activity in Diabetes|
|Study Start Date :||June 2005|
|Study Completion Date :||January 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151021
|United States, Michigan|
|University of Michigan, Department of Family Medicine|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Caroline R Richardson, MD||University of Michigan|