Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior (SMARTpath)

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 Overview

• Status: Withdrawn
• Conditions: Risk Reduction Behavior
• Intervention / Treatment: Device: Wristband; Device: Smartphone; Device: Smartphone with prompts

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparison group; Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior	Device: Wristband; Wristband will monitor activity of all participants; Other Names: Fitbit; Device: Smartphone; Smartphone will be used to monitor activity but prompts will not be given to randomly selected participants; Other Names: Android
Experimental: Intervention group; Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband	Device: Wristband; Wristband will monitor activity of all participants; Other Names: Fitbit; Device: Smartphone with prompts; Smartphone will be used to prompt randomly selected participants in intervention group to be active; Other Names: Android Smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometer-measured sedentary time	Total accelerometer-measured time spent in sedentary activity	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometer-measured sedentary breaks	Accelerometer-measured time spent in sedentary activity	26 weeks
Accelerometer-measured total active time	Total active time	26 weeks
Accelerometer-measured time spent in light, moderate, and vigorous activity	Total time spent in light, moderate, and vigorous activity	26 weeks

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Darla Kendzor, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Smartphone, sedentary behavior, smartphone intervention
• Other Study ID Numbers: 7092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No