Behavior, Binge Eating, Smoking
Conditions
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.
Interventions
BEHAVIORALLaddr
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.
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Binge Eating Group Overweight participants with binge eating disorder were administered Laddr over 4 weeks. | 46 |
| Smoking Group Participants who smoked 5 cigarettes or more per day were administered Laddr over 4 weeks. | 10 |
| Total | 56 |
Baseline characteristics
| Characteristic | Binge Eating Group | Total | Smoking Group |
|---|---|---|---|
| Age, Continuous | 32.80 years STANDARD_DEVIATION 8.27 | 34.04 years STANDARD_DEVIATION 8.67 | 39.7 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 14 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 42 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 32 Participants | 7 Participants |
| Race (NIH/OMB) White | 16 Participants | 18 Participants | 2 Participants |
| Region of Enrollment United States | 46 Participants | 56 Participants | 10 Participants |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 2 Participants |
| Sex: Female, Male Male | 10 Participants | 18 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 24 |
| other Total, other adverse events | 0 / 67 | 0 / 24 |
| serious Total, serious adverse events | 0 / 67 | 0 / 24 |
Outcome results
Primary
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.
Time frame: 28 days
Population: Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Binge Eating Group | Binge Eating Episodes - Loss of Control | 0.212 episodes | Standard Error 0.0213 |
p-value: 0.066Generalized linear mixed model
Primary
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.
Time frame: 28 days
Population: Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Binge Eating Group | Binge Eating Episodes - Overeating | 0.286 episodes | Standard Error 0.0235 |
p-value: 0.273Generalized linear mixed model
Primary
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.
Time frame: 28 days
Population: Participants in the Smoking Group only and completed both scans were evaluated for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Binge Eating Group | Number of Cigarettes Smoked Per Day | 2.97 cigarettes per day | Standard Error 0.547 |
p-value: 0.403Generalized linear mixed model