Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

NCT03094858 | Withdrawn

• 1 other identifier: 7092
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Risk Reduction Behavior

Keywords

Smartphone, sedentary behavior, smartphone intervention

Outcome Measures

Primary Outcomes (1)

• Accelerometer-measured sedentary time

  Total accelerometer-measured time spent in sedentary activity

  One week

Secondary Outcomes (3)

• Accelerometer-measured sedentary breaks

  26 weeks

• Accelerometer-measured total active time

  26 weeks

• Accelerometer-measured time spent in light, moderate, and vigorous activity

  26 weeks

Study Arms (2)

Comparison group

ACTIVE COMPARATOR

Equipment only comparison group will use Smartphone and Wristband to monitor sedentary behavior

Device: Wristband; Device: Smartphone

Intervention group

EXPERIMENTAL

Intervention group will receive prompts from Smartphone to reduce sedentary behavior using information from Wristband

Device: Smartphone with prompts; Device: Wristband

Interventions

Smartphone with prompts DEVICE

Smartphone will be used to prompt randomly selected participants in intervention group to be active

Also known as: Android Smartphone

Intervention group

Wristband DEVICE

Wristband will monitor activity of all participants

Also known as: Fitbit

Comparison group; Intervention group

Smartphone DEVICE

Smartphone will be used to monitor activity but prompts will not be given to randomly selected participants

Also known as: Android

Comparison group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

MeSH Terms

Conditions

Risk Reduction Behavior; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Darla Kendzor, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 29, 2017
• Study Start: March 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share