Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03094858
Status:
WITHDRAWN
Last Update Posted:
2021-06-11
First Post:
2017-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
Sponsor:
University of Oklahoma
Organization:
Study Overview
Official Title:
Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior
Status:
WITHDRAWN
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The smartwatches we planned to use were discontinued.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMARTpath
Brief Summary:
Participants (N = 300) will be randomly assigned to: 1) an equipment-only comparison group that receives a smartphone and an activity monitor wristband but does not receive smartphone intervention prompts, or 2) the intervention group who will receive an activity monitor wristband that works in conjunction with a smartphone to reduce sedentary time via smartphone prompts during prolonged sedentary bouts. All participants will be provided with a Fitbit® wristband activity monitor and an Android smartphone on the same day of the week (i.e., Mondays). Participants will complete a 1-week baseline accelerometer and EMA period prior to the start of the intervention. Participants will be followed for 26 weeks after the intervention begins with follow-up visits at 6, 13, and 26 weeks. The primary outcome will be accelerometer-measured time spent in sedentary activity. Sedentary breaks, total active time, and time spent in light, moderate, and vigorous activity will be additionally evaluated as outcomes. Contextual variables and potential treatment mechanisms will be assessed via traditional questionnaire measurement and daily random EMAs at baseline and all follow-up visits. Brief smartphone-based daily diary assessments will be completed daily for the duration of the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: