Can Methods From Computational Psychology be Used to Phen... | NCT04783298

Studies
Can Methods From Computational Psychology be Used to Phenotype Individuals Most Likely to be Non-adherent to Fitness Goals?

NCT04783298

Sponsor

Dublin City University

Status

Unknown status

Last Update Posted

Mar 5, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Lifestyle, Sedentary

Interventions

Countries

Ireland

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

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Feb 15, 2021

First Submission Date that Met QC Criteria

Mar 3, 2021

First Posted Date

Mar 5, 2021Actual

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

Mar 3, 2021

Last Update Posted Date

Mar 5, 2021Actual

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

This is a longitudinal study combining objective sensor data, with decision-making games and contextual personality traits to identify patterns in exercise decay. The data generated will be used to build computational models to predict digital personas, and help identify those individuals most likely to abandon exercise goals.

Detailed Description

Interested individuals to be recruited on social media and invited to download the study app. The plain language statement and informed consent are embedded in the app. Once e-consent is obtained, individuals will share their Fitbit data and complete the following questionnaires; Type D Personality, Goal Setting, and Self-Efficacy questionnaire and a decision-making game based on the IGT. After a 6 month time period, they will be requested to retake the questionnaires and decision-making game.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
App	Other	An application to deliver a series of behavioral questionnaires and decision-making game

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in physical activity measured by an increase in weekly steps measured by Fitbit.	Fitbit is a physical activity tracker worn on the wrist and objectively measures steps taken.	Week 1 and 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy individuals who have a Fitbit

Exclusion Criteria:

Individuals under the age of 18 years of age.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy individuals starting a new exercise regime.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marie Mc Carthy, MSc	Contact	+353877645817		marie.mccarthy65@mail.dcu.ie
Tomas Ward, PhD	Contact	+35317006076		Tomas.ward@dcu.ie

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dublin City University	Recruiting	Dublin			Ireland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34842557	Derived	McCarthy M, Zhang L, Monacelli G, Ward T. Using Methods From Computational Decision-making to Predict Nonadherence to Fitness Goals: Protocol for an Observational Study. JMIR Res Protoc. 2021 Nov 26;10(11):e29758. doi: 10.2196/29758.

ID	Term
D046912	Multiprotein Complexes
D046911	Macromolecular Substances
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins