Evaluation of a Smartphone Intervention to Reduce Sedentary Behavior

NCT ID: NCT03094858

Last Updated: 2021-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-04-30

Brief Summary

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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

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Conditions

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Risk Reduction Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Comparison group

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

Group Type ACTIVE_COMPARATOR

Wristband

Intervention Type DEVICE

Wristband will monitor activity of all participants

Smartphone

Intervention Type DEVICE

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

Intervention group

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

Group Type EXPERIMENTAL

Smartphone with prompts

Intervention Type DEVICE

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

Wristband

Intervention Type DEVICE

Wristband will monitor activity of all participants

Interventions

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Smartphone with prompts

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

Intervention Type DEVICE

Wristband

Wristband will monitor activity of all participants

Intervention Type DEVICE

Smartphone

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

Intervention Type DEVICE

Other Intervention Names

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Android Smartphone Fitbit Android

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Darla Kendzor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Other Identifiers

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7092

Identifier Type: -

Identifier Source: org_study_id

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