SmokingNCT03687658

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

A study testing Laddr in people with Smoking and Binge Eating, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Smoking, Binge Eating, Behavior
What is being tested?: Laddr
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2019to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Show all 11Show fewer

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)

Who cannot join

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)

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford Center for Cognitive and Neurobiological Imaging
Stanford, California, 94305

Other trials in United States

About this study

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

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
Being tested: Laddr
Medical subject headings: Smoking, Bulimia, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LaddrBehavioural
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.

Study groups in NCT03687658
Study group	Role	What they receive
Binge Eating Group	Experimental	All participants in the study will be invited to use Laddr, described in the intervention section. Receives: Behavioral: Laddr
Smoking Group	Experimental	All participants in the study will be invited to use Laddr, described in the intervention section. Receives: Behavioral: Laddr

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 201931 Aug 2022

First posted27 Sep 2018
Study start12 Sep 2019
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SmokingStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03687658
Sponsor's protocol ID: 47143
Other IDs: 4UH3DA041713-04
Status last verified: Aug 2023
First submitted: 26 Sep 2018
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation: Aim 4
ClinicalTrials.gov ID: NCT03687658
Acronym / sponsor ID: 47143
Conditions: Smoking, Binge Eating, Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: 12 Sep 2019 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 27 Sep 2018 (actual)
Results: Posted 28 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Binge Eating Group	Experimental	Behavioral: LaddrAll participants in the study will be invited to use Laddr, described in the intervention section.
Smoking Group	Experimental	Behavioral: LaddrAll participants in the study will be invited to use Laddr, described in the intervention section.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (12 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LaddrLaddr 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.	Behavioural	Binge Eating Group, Smoking Group

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 28 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Binge Eating Group	67	46
Smoking Group	24	10

Primary outcome: Binge Eating Episodes - Loss of Control

Time frame: 28 days. Mean (Standard Error). Unit: episodes

Measure	Binge Eating Group n = 46
Value	0.212 (0.0213)

Binge Eating Group: p = 0.066, Generalized linear mixed model

Population analysed: Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.

Primary outcome: Binge Eating Episodes - Overeating

Time frame: 28 days. Mean (Standard Error). Unit: episodes

Measure	Binge Eating Group n = 46
Value	0.286 (0.0235)

Binge Eating Group: p = 0.273, Generalized linear mixed model

Population analysed: Participants in the Binge Eating Group only and completed both scans were evaluated for this outcome.

Primary outcome: Number of Cigarettes Smoked Per Day

Time frame: 28 days. Mean (Standard Error). Unit: cigarettes per day

Measure	Smoking Group n = 10
Value	2.97 (0.547)

Smoking Group: p = 0.403, Generalized linear mixed model

Population analysed: Participants in the Smoking Group only and completed both scans were evaluated for this outcome.

Adverse events

Time frame: Average approximately 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Binge Eating Group	0 of 67 (0%)	0 of 67 (0%)	0 of 67
Smoking Group	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Russell A Poldrack, PhD principal investigator

Stanford University

Patrick G Bissett, PhD study director

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Laddr in people with Smoking and Binge Eating, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Binge Eating Episodes - Loss of Control (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03687658.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.