Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating

NCT ID: NCT03687658

Last Updated: 2023-09-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2022-08-31

Brief Summary

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This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain within and outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. This is the fourth phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.

Detailed Description

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Conditions

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Smoking Binge Eating Behavior

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Binge Eating Group

All participants in the study will be invited to use Laddr, described in the intervention section.

Group Type EXPERIMENTAL

Laddr

Intervention Type BEHAVIORAL

Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not "diagnosis-specific" but rather enables integrated care for any combination of individuals' goals, needs, and preferences.

Smoking Group

All participants in the study will be invited to use Laddr, described in the intervention section.

Group Type EXPERIMENTAL

Laddr

Intervention Type BEHAVIORAL

Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not "diagnosis-specific" but rather enables integrated care for any combination of individuals' goals, needs, and preferences.

Interventions

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Laddr

Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not "diagnosis-specific" but rather enables integrated care for any combination of individuals' goals, needs, and preferences.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Understand English sufficiently to provide informed consent
* Right-handed
* Normal or corrected-to-normal vision and no color blindness
* Interest in engaging with Laddr to modify self-regulatory behavior


* Smoke 5 or more tobacco cigarettes/day for past year
* BMI greater than or equal to 17 and less than 27


* BMI greater than or equal to 27 and less than 45
* Weight limit of 350 lbs
* Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)

Exclusion Criteria

* Significant medical illness
* History of mental disorder due to a medical condition
* Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
* Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)


* Lost weight in recent past (\>10 pounds in past 6 months)
* Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)
* Currently on a special diet for a serious health condition
* Current engagement in psychotherapy for binge eating disorder


* Binge eating behavior
* Current engagement in psychotherapy for smoking behavior
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Russell Alan Poldrack

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Russell A Poldrack, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Patrick G Bissett, PhD

Role: STUDY_DIRECTOR

Stanford University

Locations

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Stanford Center for Cognitive and Neurobiological Imaging

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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4UH3DA041713-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

47143

Identifier Type: -

Identifier Source: org_study_id

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