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Clinical Trials/NCT03837366
NCT03837366
Completed
Not Applicable

Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: A Randomized Intervention

Laura Ellingson-Sayen0 sites91 target enrollmentStarted: June 11, 2015Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Laura Ellingson-Sayen
Enrollment
91
Primary Endpoint
Steps

Overview

Brief Summary

Wearable fitness monitors are increasingly popular but the actual utility of these devices for promoting physical activity behavior is unknown. The purpose is to examine the efficacy of the Fitbit monitor for previously inactive individuals when used alone or following brief training in behavior change strategies and techniques. Psychosocial factors will be assessed and changes in physical activity will be monitored over three months to determine the efficacy of this intervention and to better understand individual differences in effectiveness.

Detailed Description

The objective for this pilot study is to determine the efficacy of the Fitbit Charge wearable fitness monitor alone or in combination with additional behavior change strategies for increasing physical activity in inactive adults. A secondary objective is to assess the influence of psychosocial factors (e.g. self-efficacy, self-regulation, habit formation) on the effectiveness of this type of behavior change intervention. The central hypothesis is that use of the Fitbit will increase physical activity from baseline and that adding additional strategies will enhance this effect. This hypothesis is based on previous research demonstrating that continuous self- monitoring (using wearable technology) is effective in promotion of weight-loss in overweight and obese adults. This objective will be addressed through pursuing the following specific aims.

Aim 1: To determine the efficacy of using the Fitbit to increase physical activity behaviors and improve health markers in inactive adults. The working hypothesis is that wearing a Fitbit for 3 months will increase physical activity and improve health markers from baseline to follow-up in inactive adults.

Aim 2: To compare the efficacy of the Fitbit alone to the Fitbit in combination with behavior change strategies for increasing physical activity and improving psychosocial factors in inactive adults. The working hypothesis is that using the Fitbit along with behavior change strategies will lead to greater improvements in physical activity and psychosocial factors (self- motivation, self-regulation, self-efficacy, and social support) than using the Fitbit alone.

Aim 3: To assess the influence of individual differences in psychosocial variables on changes in physical activity over the intervention. The working hypothesis is that higher levels of self- motivation, self-regulation, self-efficacy, and social support at baseline will be predictive of greater improvements in physical activity over the intervention, regardless of group assignment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Masking Description

Individuals processing outcome data are blinded to experimental condition.

Eligibility Criteria

Ages
24 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not meeting physical activity guidelines

Exclusion Criteria

  • Meeting physical activity guidelines
  • Injury or condition that limits mobility

Outcomes

Primary Outcomes

Steps

Time Frame: 3 months

Average steps accumulated per day assessed via the activPAL

Moderate and Vigorous Physical Activity

Time Frame: 3 months

Average minutes per day assessed via a combination of activPAL and ActiGraph

Secondary Outcomes

  • Habit Development(3 months)

Investigators

Sponsor
Laura Ellingson-Sayen
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Laura Ellingson-Sayen

Assistant Professor

Iowa State University

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