Physical Activity PromotionNCT03837366
Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Physical Activity
A study testing Activity tracker and health coaching in people with Physical Activity Promotion, run by Laura Ellingson-Sayen.
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… Read more about this study
- Who is it for?
- Ages 24 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity Promotion
- What is being tested?
- Activity tracker and health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 11 Jun 2015to 3 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not meeting physical activity guidelines
Who cannot join
- Meeting physical activity guidelines
- Injury or condition that limits mobility
About this study
Official title: Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: A Randomized Intervention
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.
Read the 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.
- Conditions
- Physical Activity Promotion
- Being tested
- Activity tracker and health coaching
- Keywords
- Activity tracker, Physical Activity, mHealth, habit, Motivational Interviewing
- Medical subject headings
- Motor Activity, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity tracker and health coachingBehavioural
Also called Fitbit
Use of an activity tracker alone or in combination with health coaching on physical activity behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Activity Tracker with Health Coaching | Experimental | Participants assigned to this condition will receive a Fitbit activity tracker to use for 3 months. Also, they will be asked to come in for a visit approximately one week following baseline assessments. Using the principles of Motivational Interviewing and Habit Formation, participants will discuss their perceived benefits and barriers of becoming more physically active with a member of the research team. They will also be encouraged to set a goal related to using their Fitbit to increase their physical activity. Lastly, they will be given information regarding habit formation and encouraged to identify one or more cues that regularly occur in their daily life to check their Fitbit data as a prompt to engage in physical activity. Receives: Behavioral: Activity tracker and health coaching |
| Activity Tracker alone | Active comparator | Participants assigned to this condition will use their Fitbit on their own for the duration of 3- month intervention, similar to the experience of participants buying the device off-the-shelf. Receives: Behavioral: Activity tracker and health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps
Average steps accumulated per day assessed via the activPAL
Measured: 3 months
Moderate and Vigorous Physical Activity
Average minutes per day assessed via a combination of activPAL and ActiGraph
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start11 Jun 2015
- Primary completion3 Mar 2016
- Study completion3 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical Activity PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura Ellingson-Sayen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura Ellingson-Sayen, Iowa State University
- Investigators
- Laura D Ellingson-Sayen, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837366
- Sponsor's protocol ID
- LEllingson_Fitbit_Intervention
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30762582
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Motivational Interviewing and Habit Formation to Enhance the Effect of Activity Trackers on Healthy Adults' Activity Levels: A Randomized Intervention
- ClinicalTrials.gov ID
- NCT03837366
- Acronym / sponsor ID
- LEllingson_Fitbit_Intervention
- Conditions
- Physical Activity Promotion
- Keywords
- Activity tracker, Physical Activity, mHealth, habit, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Laura Ellingson-SayenUniversity, hospital or other
- Study start
- 11 Jun 2015 (actual)
- Primary completion
- 3 Mar 2016 (actual)
- Study completion
- 3 Mar 2016 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Activity Tracker with Health Coaching | Experimental | Behavioral: Activity tracker and health coachingParticipants assigned to this condition will receive a Fitbit activity tracker to use for 3 months. Also, they will be asked to come in for a visit approximately one week following baseline assessments. Using the principles of Motivational Interviewing and Habit Formation, participants will discuss their perceived benefits and barriers of becoming more physically active with a member of the research team. They will also be encouraged to set a goal related to using their Fitbit to increase their physical activity. Lastly, they will be given information regarding habit formation and encouraged to identify one or more cues that regularly occur in their daily life to check their Fitbit data as a prompt to engage in physical activity. |
| Activity Tracker alone | Active comparator | Behavioral: Activity tracker and health coachingParticipants assigned to this condition will use their Fitbit on their own for the duration of 3- month intervention, similar to the experience of participants buying the device off-the-shelf. |
Who may qualify
- Ages
- 24 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Not meeting physical activity guidelines
Key exclusion criteria (2 listed)
- Meeting physical activity guidelines
- Injury or condition that limits mobility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity tracker and health coachingAlso: FitbitUse of an activity tracker alone or in combination with health coaching on physical activity behaviors. | Behavioural | Activity Tracker alone, Activity Tracker with Health Coaching |
Primary outcome
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
1 secondary outcome
Habit Development
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 30762582Ellingson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura D Ellingson-Sayen, PhD principal investigator
Iowa State University
Questions about this trial
What is this clinical trial studying?
A study testing Activity tracker and health coaching in people with Physical Activity Promotion, run by Laura Ellingson-Sayen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03837366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.