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

NCT03687658 | Completed Results

• 2 other identifiers: 471434UH3DA041713-04
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Binge Eating; Behavior

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Binge Eating Group

EXPERIMENTAL

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

Behavioral: Laddr

Smoking Group

EXPERIMENTAL

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

Behavioral: Laddr

Interventions

Laddr 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.

Binge Eating Group; Smoking Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stanford Center for Cognitive and Neurobiological Imaging

Stanford, California, 94305, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Smoking; Bulimia; Behavior

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Russell Poldrack, PhD
• Organization: Stanford University

poldrack@stanford.edu

(650) 497-8488

Study Officials

• Russell A Poldrack, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Patrick G Bissett, PhD

  Stanford University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: September 12, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)