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Completed

NCT Number: NCT03687658

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

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.

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Key information

Conditions

Smoking Behavior Binge Eating Bulimia Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Center for Cognitive and Neurobiological Imaging

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Binge Eating Episodes - Loss of Control

    Time frame: 28 days

    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.

  2. Binge Eating Episodes - Overeating

    Time frame: 28 days

    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.

  3. Number of Cigarettes Smoked Per Day

    Time frame: 28 days

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2018
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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