Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Physical Activity

Physical Activity Promotion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837366
• Other study ID #: LEllingson_Fitbit_Intervention
• Status: Completed
• Phase: N/A
• Start date: June 11, 2015
• Est. completion date: March 3, 2016

Study information

• Verified date: February 2019
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 3, 2016
• Est. primary completion date: March 3, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Years to 60 Years

Eligibility

Inclusion Criteria:

• Not meeting physical activity guidelines

Exclusion Criteria:

• Meeting physical activity guidelines

• Injury or condition that limits mobility

Related Conditions & MeSH terms

• Physical Activity Promotion

Intervention

Behavioral:
• Activity tracker and health coaching
Use of an activity tracker alone or in combination with health coaching on physical activity behaviors.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laura Ellingson-Sayen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steps	Average steps accumulated per day assessed via the activPAL	3 months
Primary	Moderate and Vigorous Physical Activity	Average minutes per day assessed via a combination of activPAL and ActiGraph	3 months
Secondary	Habit Development	Measured via the Automaticity Index of the Self-Reported Habit Index. The Self-Reported Habit Index consists of 12 items and the Automaticity Subscale includes 4 of these 12. Each item is scored on a 5-point (0-4) Likert scale with anchors ranging from strongly disagree (0) to strongly agree (4). As such, scores for the Automaticity Index range from 0-16 with higher scores indicating stronger habits.	3 months