Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT03094858
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.
Study:
NCT03094858
Study Brief:
Protocol Section:
NCT03094858