Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

Risk Reduction Behavior Clinical Trial

— SMARTpath  

Official title:

Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03094858
• Other study ID #: 7092
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: April 2020

Study information

• Verified date: June 2021
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• A score of = 4 on the REALM-SF85 indicating > 6th grade English literacy level, must be at least 18 years of age
• A BMI = 25 (overweight/obese), not meeting current physical activity guidelines as measured by the 7-Day Physical Activity Recall
• Do not have a contraindication for physical activity based on the Physical Activity Readiness Questionnaire (PAR-Q)
• Able to attend all study visits, and possess a valid home address and a functioning telephone number.

Exclusion Criteria:

• Participants who have physical disabilities that restrict lower limb function and/or reading skills below a 7th grade reading level.

Related Conditions & MeSH terms

• Risk Reduction Behavior

Intervention

Device:
• Smartphone with prompts
Smartphone will be used to prompt randomly selected participants in intervention group to be active
• Wristband
Wristband will monitor activity of all participants
• Smartphone
Smartphone will be used to monitor activity but prompts will not be given to randomly selected participants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accelerometer-measured sedentary time	Total accelerometer-measured time spent in sedentary activity	One week
Secondary	Accelerometer-measured sedentary breaks	Accelerometer-measured time spent in sedentary activity	26 weeks
Secondary	Accelerometer-measured total active time	Total active time	26 weeks
Secondary	Accelerometer-measured time spent in light, moderate, and vigorous activity	Total time spent in light, moderate, and vigorous activity	26 weeks