Clinical trial NCT03837366: Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Physical Activity
Official title: Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: A Randomized Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity Promotion
Keywords: Activity tracker
Physical Activity
mHealth
habit
Motivational Interviewing
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 91
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of two groups. One group received an activity tracker and the other received an activity tracker in combination with Health Coaching.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Not meeting physical activity guidelines

Exclusion Criteria:

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

Primary outcomes:
measure: Steps
timeFrame: 3 months
measure: Moderate and Vigorous Physical Activity
timeFrame: 3 months
Secondary outcomes:
measure: Habit Development
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Iowa State University
name: Laura D Ellingson-Sayen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellingson LD, Lansing JE, DeShaw KJ, Peyer KL, Bai Y, Perez M, Phillips LA, Welk GJ. Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: Randomized Intervention. JMIR Mhealth Uhealth. 2019 Feb 14;7(2):e10988. doi: 10.2196/10988.