An interventional study of Laddr in Self-regulation, Binge Eating and Smoking, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-01-10.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Basic science
This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. Fifty smokers and 50 overweight/obese individuals with binge eating disorder will be recruited to participate in a non-lab experimental paradigm in which we will leverage our novel mobile behavioral assessment/intervention technology platform. We will measure and modulate engagement of potential self-regulation targets and collect data in real time and in real-world conditions. Mobile sensing will be added to up to 50 additional participants.
Health risk behavior, including poor diet, physical inactivity, tobacco and other substance use, causes as much as 40% of the illness, suffering, and early death related to chronic diseases. Non-adherence to medical regimens is an important exemplar of the challenges in changing health behavior and its associated impact on health outcomes. Although an array of interventions has been shown to be effective in promoting initiation and maintenance of health behavior change, the mechanisms by which they actually work are infrequently systematically examined. One promising domain of mechanisms to be examined across many populations and types of health behavior is of self-regulation. Self-regulation involves identifying one's goals, and maintaining goal-directed behavior. A large scientific literature has identified the role of self-regulation as a potential causal mechanism in promoting health behavior.
Advances in digital technologies have created unprecedented opportunities to assess and modify self-regulation and health behavior. In this project, we plan to use a systematic, empirical process to integrate concepts across the divergent self-regulation literatures to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.
This multi-year, multi-institution project aims to identify an array of putative psychological and behavioral targets within the self-regulation domain implicated in medical regimen adherence and health behavior. This is in service of developing an "ontology" of self- regulation that will provide structure and integrate concepts across diverse literatures. We aim to examine the relationship between various constructs within the self-regulation domain, the relationship among measures and constructs across multiple levels of analysis, and the extent to which these patterns transcend population and context. The project consists of four primary aims:
Aim 1. Identify an array of putative targets within the self-regulation domain implicated in medical regimen adherence and health behavior across these 3 levels of analysis. We will build on Multiple PI Russ Poldrack's pioneering "Cognitive Atlas" ontology to integrate concepts across divergent literatures to develop an "ontology" of self-regulatory processes. Our expert team will catalog tasks in the self-regulation literature, implement tasks via online testing (Mechanical Turk) to rapidly obtain large datasets of self-regulatory function, assess the initial ontology via confirmatory factor analysis and structural equation modeling, and assess and revise the resulting ontology according to neural similarity patterns across tasks (to identify tasks for Aim 2).
Aim 2. Evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain both within and outside of laboratory settings. Fifty smokers and 50 overweight/obese persons with binge eating disorder will participate in a lab study (led by Poldrack) to complete the tasks identified under Aim 1. We will experimentally modulate engagement of targets (e.g., stimulus set of highly palatable foods images or tobacco-related images as well as self-regulation interventions). A comparable sampling of 100 persons will participate in a non-lab study (led by Multiple PI Lisa Marsch) in which we will leverage our novel mobile-based behavioral assessment/intervention platform to modulate target engagement and collect data in real-world conditions.
Aim 3. Identify or develop measures and methods to permit verification of target engagement within the self-regulation domain. Led by Co-I Dave MacKinnon, we will examine cross-assay validity and cross-context and cross-sample reliability of assays. We will employ discriminant and divergent validation methods and Bayesian modeling to refine an empirically-based ontology of self-regulatory targets (to be used in Aim 4).
Aim 4. We will evaluate the degree to which engaging targets produces a desired change in medical regimen adherence (across 4 week interventions) and health behavior among smokers (n=100) and overweight/obese persons with binge eating disorder (n=100) (objectively measured smoking in the former sample and binge eating in the latter sample). We will employ our novel mobile behavioral assessment/intervention platform to engage targets in these samples, given that (1) it offers self-regulation assessment and behavior change tools via an integrated platform to a wide array of populations, and (2) content within the platform can be quickly modified as needed to better impact targets. The proposed project is designed to identify valid and replicable assays of mechanisms of self-regulation across populations to inform an ontology of self-regulation that can ultimately inform development of health behavior interventions of maximal efficacy and potency.
This protocol details the Aim 2 non-lab study led by Multiple PI Marsch.
This phase of the study takes what we learned about self-regulation in the first phase and tests it in two samples that are exemplary for "lapses" in self-regulation: individuals who smoke and overweight/obese individuals with binge eating disorder. We expect that many real-world conditions (e.g., temptation, negative affect) may decrease self-regulation, whereas training through the mobile intervention described below may increase self-regulation. The primary purpose of this study is to determine whether we can shift self-regulation for the ultimate goal (in Aim 4) of targeting self-regulation to impact health behaviors.
168 studies on the registry are indexed under Self-Control; 22 are open to participants now.
This study's enrollment of 185 is above the median of 88 across 144 interventional studies indexed under Self-Control.
Browse Self-Control studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 488 studies on the registry; 71 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 21 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional inclusion criteria for binge eating sample:
Additional inclusion criteria for smoking sample:
Exclusion criteria:
Any current substance use disorder
o Will not exclude based on use of substances
Current use of any medication for smoking
Additional exclusion criteria for binge eating sample:
Additional exclusion criteria for smoking sample:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
12-item Momentary Self-regulation Questionnaire
Self-reported momentary self-regulation assessed by the momentary self-regulation questionnaire four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. Each item is scored 1 (not at all) to 5 (extremely). The scale is comprised of four subscales: momentary perseverance, momentary sensation seeking, momentary self-judgment, and momentary mindfulness. Each subscale score is calculated by averaging the responses from three of the scale items. Scores on each subscale range from 1 to 5, with higher subscale scores indicating greater momentary reporting of that facet of self-regulation (perseverance, sensation seeking, self-judgment, or mindfulness).
Time frame: 14 days
Binge Eating Episodes [Binge Eating Sample Only]
\[Binge eating sample only\] Self-reported binge eating episodes assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. 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). Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 1 (not at all) to 5 (totally), where a 4 or 5 is considered loss of control.
Time frame: 14 days
Smoking Episodes [Smoking Sample Only]
\[Smoking sample only\] Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. 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.
Time frame: 14 days
| Milestone | Laddr |
|---|---|
| Started | 185 |
| Completed | 159 |
| Not completed | 26 |
| Withdrew: Lost to follow-up | 8 |
| Withdrew: Withdrawn by investigator | 5 |
| Withdrew: Completed 0 emas | 8 |
| Withdrew: Device incompatible/stolen | 5 |
Self-reported momentary self-regulation assessed by the momentary self-regulation questionnaire four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. Each item is scored 1 (not at all) to 5 (extremely). The scale is comprised of four subscales: momentary perseverance, momentary sensation seeking, momentary self-judgment, and momentary mindfulness. Each subscale score is calculated by averaging the responses from three of the scale items. Scores on each subscale range from 1 to 5, with higher subscale scores indicating greater momentary reporting of that facet of self-regulation (perseverance, sensation seeking, self-judgment, or mindfulness).
| scores on a scale | Laddr |
|---|---|
| Momentary Perseverance | 3.0 ± 1.2 |
| Momentary Sensation Seeking | 2.2 ± 0.8 |
| Momentary Self-Judgment | 1.9 ± 1.1 |
| Momentary Mindfulness | 3.9 ± 1.1 |
\[Binge eating sample only\] Self-reported binge eating episodes assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. 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). Loss of control is assessed by the question "When you ate most recently, did you lose control over your eating?" and is scored as 1 (not at all) to 5 (totally), where a 4 or 5 is considered loss of control.
| binge eating episodes | Laddr |
|---|---|
| Binge Eating Episodes [Binge Eating Sample Only] | 350 |
\[Smoking sample only\] Self-reported smoking assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 14-day period. 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.
| smoking episodes | Laddr |
|---|---|
| Smoking Episodes [Smoking Sample Only] | 2891 |
Collected over Adverse event data for each participant were collected from enrollment through the end of the study period (up to 6 weeks).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Laddr | 0/185 (0%) | 0/185 (0%) | 0/185 (0%) |
| Age, Continuous(years) | Laddr |
|---|---|
| Mean | 35.2 ± 7.9 |
| Sex/Gender, Customized(Participants) | Laddr |
|---|---|
| Male | 37 |
| Female | 145 |
| Non-binary/third gender | 3 |
| Ethnicity (NIH/OMB)(Participants) | Laddr |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 179 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Laddr |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 12 |
| White | 165 |
| More than one race | 7 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Laddr |
|---|---|
| United States | 185 |
| Short Form Self-Regulation Questionnaire (SSRQ)(units on a scale) | Laddr |
|---|---|
| Mean | 102.5 ± 17.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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. Before 3/22/2018: Informed consent procedures will ensure that participants are aware and opt into the free sharing of this open data set. Participants may consent to participate in the study without consenting to be included in the open data set, in which case their data will be excluded from the open data set. From 3/22/2018 forward: Informed consent procedures will ensure that participants are aware that consenting to participate in the study means consenting to inclusion in this open data set.
Ran from Jan 2018 to primary completion in Nov 2018, 10 months.
Results were first posted in Jan 2020, 1 year 1 month after primary completion.
Of 104 non-industry interventional studies with no phase under Self-Control, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 10 months is below that.
Counting every sponsor, half of 105 studies reached it within 16 months; a quarter within 5 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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