NCT03352713

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 11, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 10, 2020

Completed
Last Updated

January 10, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

November 21, 2017

Results QC Date

November 27, 2019

Last Update Submit

December 22, 2019

Conditions

Self-regulationBinge EatingSmoking

Keywords

self-regulationbinge eatingsmokingecological momentary assessmentmobile sensingmHealth

Outcome Measures

Primary Outcomes (1)

  • 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).

    14 days

Secondary Outcomes (2)

  • Binge Eating Episodes [Binge Eating Sample Only]

    14 days

  • Smoking Episodes [Smoking Sample Only]

    14 days

Study Arms (1)

Laddr

EXPERIMENTAL

All participants in the study will be invited to use Laddr, described in the intervention section.

Behavioral: Laddr

Interventions

LaddrBEHAVIORAL

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.

Laddr

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 21-50 years
  • Understand English sufficiently to provide informed consent
  • Use a smartphone (participants without mobile sensing); proficient with using smartphone and comfort wearing devices (participants with mobile sensing)
  • ≤ BMI ≤ 45 kg/m2
  • Have binge eating disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
  • Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)
  • Smoke 5 or more tobacco cigarettes/day for past year
  • ≤ BMI \< 27 kg/m2

You may not qualify if:

  • Any current substance use disorder
  • o Will not exclude based on use of substances
  • Currently pregnant or plans to become pregnant in next 3 months
  • Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
  • Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)
  • Current use of prescription pain medications (e.g., Vicodin, oxycodone)
  • Current use of any medication for smoking
  • Exceptions: short-acting nicotine replacement therapy (e.g., gum, lozenge, nasal spray, inhaler)
  • Will screen out for Wellbutrin or varenicline
  • Current use of any medication for weight loss
  • Have undergone weight-loss surgery (e.g., gastric bypass, lap band)
  • Current nighttime shift work or obstructive sleep apnea
  • Note: We will not exclude based on e-cigarette use.
  • Compensatory behavior (e.g., purging, excessive exercise, fasting) \[already excluded as part of the DSM-5 binge eating disorder criteria\]
  • Lost weight in recent past (\>10 pounds in past 6 months)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Technology and Behavioral Health, Dartmouth College

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (2)

  • Eisenberg IW, Bissett PG, Canning JR, Dallery J, Enkavi AZ, Whitfield-Gabrieli S, Gonzalez O, Green AI, Greene MA, Kiernan M, Kim SJ, Li J, Lowe MR, Mazza GL, Metcalf SA, Onken L, Parikh SS, Peters E, Prochaska JJ, Scherer EA, Stoeckel LE, Valente MJ, Wu J, Xie H, MacKinnon DP, Marsch LA, Poldrack RA. Applying novel technologies and methods to inform the ontology of self-regulation. Behav Res Ther. 2018 Feb;101:46-57. doi: 10.1016/j.brat.2017.09.014. Epub 2017 Oct 5.

    PMID: 29066077BACKGROUND

  • Scherer EA, Metcalf SA, Whicker CL, Bartels SM, Grabinski M, Kim SJ, Sweeney MA, Lemley SM, Lavoie H, Xie H, Bissett PG, Dallery J, Kiernan M, Lowe MR, Onken L, Prochaska JJ, Stoeckel LE, Poldrack RA, MacKinnon DP, Marsch LA. Momentary Influences on Self-Regulation in Two Populations With Health Risk Behaviors: Adults Who Smoke and Adults Who Are Overweight and Have Binge-Eating Disorder. Front Digit Health. 2022 Mar 18;4:798895. doi: 10.3389/fdgth.2022.798895. eCollection 2022.

    PMID: 35373179DERIVED

MeSH Terms

Conditions

Self-ControlBulimiaSmoking

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorHyperphagiaSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Shea Lemley
Organization
Center for Technology and Behavioral Health, Dartmouth Geisel School of Medicine
behavior.change@dartmouth.edu
603-646-7040

Study Officials

  • Lisa A Marsch, PhD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andrew G. Wallace Professor; Director, Center for Technology and Behavioral Health

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 24, 2017

Study Start

January 11, 2018

Primary Completion

November 29, 2018

Study Completion

December 3, 2018

Last Updated

January 10, 2020

Results First Posted

January 10, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)