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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 : Not yet recruiting
First Posted : September 27, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Russell Alan Poldrack, Stanford University

Tracking Information
First Submitted Date  ICMJE September 26, 2018
First Posted Date  ICMJE September 27, 2018
Last Update Posted Date October 17, 2018
Estimated Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03687658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
Official Title  ICMJE Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Smoking
  • Binge Eating
  • Behavior
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Binge Eating Group
    All participants in the study will be invited to use Laddr, described in the intervention section.
    Intervention: Behavioral: Laddr
  • Experimental: Smoking Group
    All participants in the study will be invited to use Laddr, described in the intervention section.
    Intervention: Behavioral: Laddr
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 26, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: McKenzie P Hagen 360-840-0434 mphagen@stanford.edu
Contact: Jaime Li jamieli@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03687658
Other Study ID Numbers  ICMJE 47143
4UH3DA041713-04 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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.
Responsible Party Russell Alan Poldrack, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Russell A Poldrack, PhD Stanford University
Study Director: Patrick G Bissett, PhD Stanford University
PRS Account Stanford University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP