Applying Novel Technologies and Methods to Self-Regulation: Behavior Change Tools for Smoking and Binge Eating
- Conditions
- SmokingBinge EatingBehavior
- Interventions
- Behavioral: Laddr
- Registration Number
- NCT03687658
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Binge Eating Group Laddr All participants in the study will be invited to use Laddr, described in the intervention section. Smoking Group Laddr All participants in the study will be invited to use Laddr, described in the intervention section.
- Primary Outcome Measures
Name Time Method Binge Eating Episodes - Overeating 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.
Number of Cigarettes Smoked Per Day 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.
Binge Eating Episodes - Loss of Control 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford Center for Cognitive and Neurobiological Imaging
🇺🇸Stanford, California, United States