Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

Not Applicable

Withdrawn

• Conditions: Risk Reduction Behavior
• Interventions: Device: Smartphone with prompts; Device: Wristband; Device: Smartphone

• Registration Number: NCT03094858
• Lead Sponsor: University of Oklahoma

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

Not available

Study Timeline

• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-29
• Study Start: 2019-03-01
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Wristband	Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband
Comparison group	Wristband	Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior
Intervention group	Smartphone with prompts	Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband
Comparison group	Smartphone	Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior

Primary Outcome Measures

Name	Time	Method
Accelerometer-measured sedentary time	One week	Total accelerometer-measured time spent in sedentary activity

Secondary Outcome Measures

Name	Time	Method
Accelerometer-measured time spent in light, moderate, and vigorous activity	26 weeks	Total time spent in light, moderate, and vigorous activity
Accelerometer-measured sedentary breaks	26 weeks	Accelerometer-measured time spent in sedentary activity
Accelerometer-measured total active time	26 weeks	Total active time