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

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ClinicalTrials.gov Identifier: NCT03687658
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Russell Alan Poldrack, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Binge Eating Behavior Behavioral: Laddr Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Binge Eating Group
All participants in the study will be invited to use Laddr, described in the intervention section.
Behavioral: 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.

Experimental: Smoking Group
All participants in the study will be invited to use Laddr, described in the intervention section.
Behavioral: 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.




Primary Outcome Measures :
  1. Binge eating episodes [binge eating sample only] [ Time Frame: 28 days ]
    [Binge eating sample only] Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-day period. A binge eating episode is defined as self-reported overeating and loss of control. Overeating is assessed by the question "Since the last prompt, when you ate most recently, did you overeat?" and is scored as 0 (no) or 1 (yes). Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 1 (not at all) to 5 (totally), where a 4 or 5 is considered loss of control.

  2. Smoking episodes [smoking sample only] [ Time Frame: Time Frame: 28 days] ]
    [Smoking sample only] Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-day period. A smoking episode is defined as self-reported smoking of more than zero cigarettes and is assessed by the question "Since the last prompt, how many cigarettes have you smoked?" Participants are asked to input a number into a number field.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Additional Inclusion Criteria for Smoking sample:

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

Additional Inclusion Criteria for Binge Eating Sample:

  • 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)

Additional Exclusion criteria for Binge Eating Sample:

  • 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

Additional Exclusion Criteria for Smoking Sample:

  • Binge eating behavior
  • Current engagement in psychotherapy for smoking behavior

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687658


Contacts
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Contact: McKenzie P Hagen 650-492-5740 mphagen@stanford.edu
Contact: Tung Bui 650-492-5740 tungb@stanford.edu

Locations
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United States, California
Stanford Center for Cognitive and Neurobiological Imaging Recruiting
Stanford, California, United States, 94305
Contact: McKenzie Hagen    650-492-5740    mphagen@stanford.edu   
Contact: Tung T Bui    650-492-5740    tungb@stanford.edu   
Principal Investigator: Russell A Poldrack         
Sub-Investigator: Patrick Bissett         
Sub-Investigator: Cara Bohan         
Sub-Investigator: Judith Prochaska         
Sub-Investigator: Amy Chieng         
Sub-Investigator: McKenzie Hagen         
Sub-Investigator: Hannah Welch         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Russell A Poldrack, PhD Stanford University
Study Director: Patrick G Bissett, PhD Stanford University

Additional Information:
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Responsible Party: Russell Alan Poldrack, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03687658     History of Changes
Other Study ID Numbers: 47143
4UH3DA041713-04 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, a de-identified dataset (i.e., stripped of all codes or other information that could be linked back to an individual participant) will be generated and made available to the research community as a whole.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available upon submission of the paper detailing the findings of the research.
Access Criteria: All data will be shared openly, with no restrictions on access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bulimia
Binge-Eating Disorder
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders