HealthyNCT03744052
Using Neuroscience to Optimize Digital Health Interventions Across Adulthood
A study testing Motivational Messages in people with Healthy, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to investigate the extent to which brain imaging data predict health behavior change, compared to participant self-reports. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Motivational Messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2019to 18 May 2020
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults ages 30-80 who read/understand English, 50% male and 50% female, and a maximum of 50% will be white.
Who cannot join
- Pregnancy
- History of head injury
- Mental illness diagnosis
- Psychoactive medication
- Psychiatric or neurological history
- Claustrophobia
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- Ferrous metal implanted within the body (those with fMRI-compatible implanted devices will not be excluded, but the eligibility of their devices will be first verified.)
- Asthma, injuries, or other health conditions which inhibit daily physical activity
- Subjects must not already meet the recommended amount of physical activity of moderate-intensity physical activity for 150 minutes a week or 75 minutes at vigorous-intensity a week.
- Duke students are excluded from this study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to investigate the extent to which brain imaging data predict health behavior change, compared to participant self-reports.
- Conditions
- Healthy
- Being tested
- Motivational Messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational MessagesOther
Messages regarding physical activity will be texted to participants.
| Study group | Role | What they receive |
|---|---|---|
| Adult Participants | Experimental | Messages regarding physical activity will be texted to participants. Receives: Other: Motivational Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity as measures by FitBit
Measured: Baseline (14 days after the 1st visit), End of study (80 days after the MR visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start17 Jan 2019
- Primary completion18 May 2020
- Study completion18 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University: Bass Connections, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Gregory Samanez-Larkin, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744052
- Sponsor's protocol ID
- Pro00100499
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2018
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Neuroscience to Optimize Digital Health Interventions Across Adulthood
- ClinicalTrials.gov ID
- NCT03744052
- Acronym / sponsor ID
- Pro00100499
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke University: Bass Connections, National Institutes of Health (NIH)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 16 Nov 2018 (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.
The goal of this study is to investigate the extent to which brain imaging data predict health behavior change, compared to participant self-reports.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Participants | Experimental | Other: Motivational MessagesMessages regarding physical activity will be texted to participants. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults ages 30-80 who read/understand English, 50% male and 50% female, and a maximum of 50% will be white.
Key exclusion criteria (10 listed)
- Pregnancy
- History of head injury
- Mental illness diagnosis
- Psychoactive medication
- Psychiatric or neurological history
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 |
|---|---|---|
| Motivational MessagesMessages regarding physical activity will be texted to participants. | Other | Adult Participants |
Primary outcome
Change in Physical Activity as measures by FitBit
Time frame: Baseline (14 days after the 1st visit), End of study (80 days after the MR visit)
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 16 Feb 2021.
- 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.
Gregory Samanez-Larkin, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Messages in people with Healthy, run by Duke University at 1 site in United States.
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 10 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 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in Physical Activity as measures by FitBit (time frame: Baseline (14 days after the 1st visit), End of study (80 days after the MR visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2021.