Using Neuroscience to Optimize Digital Health Interventio... | NCT03744052

Studies
Using Neuroscience to Optimize Digital Health Interventions Across Adulthood

NCT03744052

Sponsor

Duke University

Status

Completed

Last Update Posted

Feb 16, 2021Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Motivational Messages

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2019Actual

Primary Completion Date

May 18, 2020Actual

Completion Date

May 18, 2020Actual

First Submitted Date

Nov 13, 2018

First Submission Date that Met QC Criteria

Nov 15, 2018

First Posted Date

Nov 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2021

Last Update Posted Date

Feb 16, 2021Actual

Name	Class
Duke University: Bass Connections	UNKNOWN
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult Participants	Experimental	Messages regarding physical activity will be texted to participants.	Other: Motivational Messages

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational Messages	Other	Messages regarding physical activity will be texted to participants.	Adult Participants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Physical Activity as measures by FitBit		Baseline (14 days after the 1st visit), End of study (80 days after the MR visit)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults ages 30-80 who read/understand English, 50% male and 50% female, and a maximum of 50% will be white.

Exclusion Criteria:

Pregnancy
History of head injury
Mental illness diagnosis
Psychoactive medication
Psychiatric or neurological history
Claustrophobia
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Samanez-Larkin, PhD	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University		Durham	North Carolina	27708	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided