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

Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4

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.

Study Overview

• Status: Completed
• Conditions: Smoking; Behavior; Binge Eating
• Intervention / Treatment: Behavioral: Laddr

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Center for Cognitive and Neurobiological Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge Eating Episodes - Loss of Control	Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). A binge eating episode is defined as self-reported overeating and loss of control. Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 0 (No), 1 (Yes). Responses provided were averaged across the 28-day period.	28 days
Binge Eating Episodes - Overeating	Self-reported binge eating episodes is assessed four times daily (morning, early afternoon, late afternoon/evening, and night). 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). Responses provided were averaged across the 28-day period.	28 days
Number of Cigarettes Smoked Per Day	Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night). 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 and this was averaged over the 28 day period.	28 days

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Russell A Poldrack, PhD, Stanford University; Study Director: Patrick G Bissett, PhD, Stanford University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2019
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Bulimia; Binge-Eating Disorder
• Other Study ID Numbers: 47143; 4UH3DA041713-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data will be available upon submission of the paper detailing the findings of the research.
• IPD Sharing Access Criteria: All data will be shared openly, with no restrictions on access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No