Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06372327 |
| Other study ID # |
73468 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
July 2026 |
Study information
| Verified date |
April 2024 |
| Source |
Stanford University |
| Contact |
Instructor of Medicine, PhD |
| Phone |
(408)314-2629 |
| Email |
moppezzo[@]stanford.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to assess a novel, widely-accessible intervention to both
promote active breaks from work and improve cognitive and psychological performances at work
in motivationally-accessible bouts. This will be done by interrupting prolonged sitting with
1-4 short (1-4 minutes), moderate-to-vigorous physical activity (MVPA) bouts with no
equipment, and simple video-based instructions. The short bouts will be referred to as
"exercise snacks." In this proposed exercise snacks intervention, investigators explicitly
target a population with sedentary jobs due to the generalizability.
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:
1. 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.
2. Nightly reporting: Participants will be sent nightly texts to track progress on
snacktivities as well as productivity, alertness, and physical energy.
3. 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.
4. 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.
5. 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.
6. 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.
