- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02958189
Tweet4Wellness: An Online Virtual Support Group for Promoting Increased Physical Activity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sedentary behavior is a risk factor for heart disease, independent of meeting physical activity guidelines. Tweet4Wellness is an innovative light physical activity, specifically walking, intervention which randomly assigns participants to a 25-person private, online support group that will receive daily, theory-based messages as peer-to-peer discussion prompts. Many text-based interventions do not base the intervention text messages in behavior change theory, but this study will base the daily messages in the behavior change theories such as implementation intentions, social support, mindfulness, and social learning theory.
The trial will be conducted over a 6-month periods. For the first 3 months, there will be 2 groups: Group 1 will receive the Twitter intervention and a "Fitbit" triaxial pedometer to track their steps throughout the day; Group 2 will receive the Fitbit pedometer only.
For the second 3 months: Group 1 an Group 2 will track their physical activity with Fitbit only.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305-7240
- Stanford University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Are a woman
- Are over 18 years of age
- Are English speaking
- Have or are willing to purchase a mobile phone with a camera
- Have or are willing to purchase an unlimited text plan
- Are willing to participate in daily tweets or texts for up to 3 months
- Have an active email account
- Have internet access on your mobile phone
- Use or are familiar with Facebook, Twitter, or other social media
- Text at least weekly
Exclusion Criteria:
- Have certain symptoms or conditions that would not be conducive to increasing your physical activity as determined by your physician
- Are planning on becoming pregnant in the next 8 months
- If our screening survey indicates that you are already adequately physically active
- Do not provide all required personal contact information
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1: Tweet4Wellness+Self-monitoring
This group will receive the Tweet4Wellness intervention: daily theory-based peer-to-peer discussion prompt within the private Twitter-based support group for the entire 6 months of the study.
They will also receive the Fitbit triaxial pedometer that will track their daily steps (self-monitoring component).
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A daily, behavior change theory-based intervention message is sent to a private, 25-person online Twitter-support group to prompt peer-to-peer discussion.
Participants receive individual text messages to encourage group participation (e.g.
'thank you for participating' or 'please participate tomorrow').
Participants also receive weekly individual messages giving them daily step goals for the week based on their previous week's daily step average, recorded from Fitbit.
A Fitbit is provided to the group which tracks participants' daily steps.
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Active Comparator: Group 2: Self-monitoring
This group will receive the Fitbit triaxial pedometer that will track their daily steps (self-monitoring component) for the first 3 months.
For the second three months of the study, they will receive the Tweet4Wellness intervention in addition to their Fitbit self-monitoring.
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A Fitbit is provided to the group which tracks participants' daily steps.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in steps (physical activity)
Time Frame: Baseline to 3 months and 6 months
|
Steps measured by triaxial accelerometer
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Baseline to 3 months and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Support Group Engagement during the intervention
Time Frame: 3 months
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Measured by # of Tweets per day sent to the group
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3 months
|
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average length of prolonged sedentary periods per day
Time Frame: baseline to 3 months and 6 months
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average length of uninterrupted sedentary periods per day over a seven day period
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baseline to 3 months and 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Judith Prochaska, PhD, Stanford University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 32127
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.