- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06372327
Move Often eVery Day 2.0 (MOVD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will answer a short 5-10-minute survey to determine eligibility. Eligible candidates will be invited to attend a 30-minute self-directed orientation session to provide a description of the consent form, study objectives and time commitments, the purpose of randomization, and the importance of completing follow-up assessments regardless of outcome. After the orientation sessions, interested and eligible individuals will be sent the e-consent form.
After participants consent to the study, they will be invited to take the baseline survey, and get assistance with study account set-ups (Garmin, GroupMe). Researchers will handle account set ups. Participants will be asked to download both apps and sign into the apps with the study provided accounts. Many individuals may have GroupMe accounts and will be asked to make a profile for their buddy chat with whatever name they prefer (able to hide their real name if preferred). Baseline measures will last for 2 weeks. And then the 6-week intervention will begin.
All consented participants will receive a 6-week intervention. The study is a 2x2 factorial design with 4 different group. We will be assessing the length of snacktivities (1 minute versus 4 minutes) as well as frequency of snacktivities through the day (1 per day versus 4 per day). Therefore, participants will be randomized into 4 groups: One 1-minute snacktivity per day, four 1-minute snacktivities per day, one 4-minute snacktivity per day, or four 4-minute snacktivities per day.
The intervention will consist of the following empirically supported components shown to promote engagement, adherence, and behavior change:
- Self-monitoring of activity: Participants will be instructed to timestamp and track their snacktivities each day using their phone. Each participant will receive bracelets (1 or 4) that can used to track progress. For example, participants will be taught how they can move the bracelets from one arm to the other to act as a visual aid of how many snacktivities they have done each day.
- Nightly reporting: Participants will be sent nightly texts to track progress on snacktivities as well as productivity, alertness, and physical energy.
- Weekly progress reports and tailored feedback: Each week of completion the participant will get a report of their adherence to the protocol for that week and their goals for next week. Embedded in the progress report will be a link for an interactive action plan survey to plan next week's exercises; the action plan is personalized, and incorporates motivational interviewing and problem-solving strategies. Action planning has high acceptability and is identified as an effective behavioral technique that enhances self-monitoring.
- Relatable modeling: Social modeling theory supports the use of relatable models representing the learner in behavior change and motivation. Dr. Oppezzo's previous work showed high acceptability when the exercise video models were representative of a diverse -body, -ethnicity, and -aged population. Each snacktivity instructional video will feature diverse models performing the moves in work clothes.
- Barrier problem solving: At baseline, study team members will work with participants to identify a feasible, safe, and comfortably private workday location for performing the activity breaks.
- Peer support: participants will be assigned a peer buddy who will act as a health-buddy motivational coach. This person will be in a private group-chat with their designated buddy (another participant) and our study account. The study account will monitor conversation and give motivational prompts, when needed, to boost conversation amongst the 2 buddies.
During the maintenance phase (after the intervention phase and lasting 6 months), participants will take part in booster sessions. The first 2 booster sessions will be completed every month, and the following 2 booster sessions will be completed every 6 weeks, following a scaffolded design to ease participants off of the program.
During the follow-up, investigators will collect behavioral data only via zoom. At the end of the study, we will conduct semi-structured interviews on study experience.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305-7240
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be 30 years of age or older.
- English speaking
- Sedentary job with 90% of the work day sitting
- Not currently taking regular activity breaks at work
Exclusion Criteria:
- Yes to any Physical Activity Readiness Questionnaire questions or any condition where increased activity is contraindicated
- Currently doing another worksite physical activity intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1 x 1 minute Exercise Snack / Day
Participants will be assigned a daily goal of 1, 1-minute exercise snack to break up prolonged sitting.
|
Participants will be encouraged to break up prolonged sitting at work with brief, high-intensity exercise snacks of varying length / total number depending on condition assignment.
|
|
Experimental: 1 x 4 Exercise Snack / Day
Participants will be assigned a daily goal of 1, 4-minute exercise snack to break up prolonged sitting.
|
Participants will be encouraged to break up prolonged sitting at work with brief, high-intensity exercise snacks of varying length / total number depending on condition assignment.
|
|
Experimental: 4x1 Exercise Snacks / Day
Participants will be assigned a daily goal of 4, 1-minute exercise snack to break up prolonged sitting.
|
Participants will be encouraged to break up prolonged sitting at work with brief, high-intensity exercise snacks of varying length / total number depending on condition assignment.
|
|
Experimental: 4x4 Exercise Snacks/Day
Participants will be assigned a daily goal of 4, 4-minute exercise snack to break up prolonged sitting.
|
Participants will be encouraged to break up prolonged sitting at work with brief, high-intensity exercise snacks of varying length / total number depending on condition assignment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of self-reported exercise snack breaks at work at week 7
Time Frame: Collected 1 work week at week 7 (the week after the 6 week intervention)
|
For the post-test week after the 6 week intervention, participants will self-report the number of exercise snacks they do each day.
|
Collected 1 work week at week 7 (the week after the 6 week intervention)
|
|
Number of self-reported exercise snack breaks at work at week 18
Time Frame: collected 1 work week at week 18 (3 months after the intervention)
|
For one week (at week 18) participants will self-report the number of exercise snacks they do each day.
|
collected 1 work week at week 18 (3 months after the intervention)
|
|
Number of self-reported exercise snack breaks at work at week 30 during follow-up
Time Frame: collected 1 work week at week 30 (6 months after the intervention)
|
For one week (at week 30) participants will self-report the number of exercise snacks they do each day.
|
collected 1 work week at week 30 (6 months after the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Liking of exercise snacks
Time Frame: at week 7, post test, immediately after 6 weeks of treatment
|
5-point likert scale From not at all to extremely of how much did you like doing exercise snacks
|
at week 7, post test, immediately after 6 weeks of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marily Oppezzo, PhD, Stanford University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 73468
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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