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Using Mobile Technology to Improve Self-Regulation

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ClinicalTrials.gov Identifier: NCT03774433
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lisa A. Marsch, Dartmouth-Hitchcock Medical Center

Brief Summary:

This study 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=50) and overweight/obese persons with binge eating disorder (n=50) (smoking in the former sample and binge eating in the latter sample). The investigators will employ a 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. This is the fourth and final phase of a study that aims to identify putative mechanisms of behavior change to develop an overarching "ontology" of self-regulatory processes.

This trial builds on NCT03352713.


Condition or disease Intervention/treatment Phase
Self-regulation Binge Eating Smoking Behavioral: Laddr Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation - Aim 4 Dartmouth Study: Using Mobile Technology to Improve Self-Regulation
Actual Study Start Date : February 27, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: Laddr
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.




Primary Outcome Measures :
  1. Rate of binge eating episodes [binge eating sample only] [ Time Frame: 28 days ]
    [Binge eating sample only] Self-reported binge eating episodes are assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-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.

  2. Rate of smoking episodes [smoking sample only] [ Time Frame: 28 days ]
    [Smoking sample only] Self-reported smoking is assessed four times daily (morning, early afternoon, late afternoon/evening, and night) over a 28-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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age 18-50 years
  • Understand English sufficiently to provide informed consent
  • Access to a computer in a setting in which the participant is comfortable providing sensitive information
  • Use a smartphone operating system compatible with Laddr

Additional inclusion criteria for binge eating sample:

  • 27 ≤ BMI ≤ 45 kg/m2
  • Have binge eating disorder according to DSM-5 criteria
  • Non-smoking (defined as no cigarettes in past 12 months—this includes former and never smokers)
  • Confirmed interest in an eating intervention
  • Use a smartphone compatible with Fitbit

Additional inclusion criteria for smoking sample:

  • Smoke 5 or more tobacco cigarettes/day for past year
  • 17 ≤ BMI < 27 kg/m2
  • Confirmed interest in a smoking quit attempt
  • Use a smartphone compatible with the iCO Smokerlyzer

Exclusion criteria:

  • Enrolled in Aim 2 study
  • 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 mental disorder due to a medical condition
  • Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
  • Current use of prescription pain medications (e.g., Vicodin, oxycodone)
  • Current use of any medication for smoking (e.g., Wellbutrin, varenicline)

    o Exceptions: will not screen out for nicotine replacement therapy (e.g., patch, gum, lozenge, nasal spray, inhaler)

  • 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.

Additional exclusion criteria for binge eating sample:

  • Compensatory behavior (e.g., purging, excessive exercise, fasting)

    o Already excluded as part of the DSM-5 binge eating disorder criteria

  • Lost weight in recent past (>10 pounds in past 6 months)
  • Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig)

    o Will ask about, but won't exclude on, online/mobile app weight-loss programs as part of the screener

  • Currently on a special diet for a serious health condition
  • Currently in therapy with a clinician for binge eating
  • Nickel allergy (because Fitbit band contains nickel)

Additional exclusion criteria for smoking sample:

  • Currently in therapy with a clinician for smoking
  • Binge eating behavior

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774433


Contacts
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Contact: Shea Lemley, PhD 603-646-7040 behavior.change@dartmouth.edu
Contact: Hannah Lavoie, BA 603-646-7040 behavior.change@dartmouth.edu

Locations
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United States, New Hampshire
Center for Technology and Behavioral Health, Dartmouth College Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Shea Lemley, PhD    603-646-7040    behavior.change@dartmouth.edu   
Contact: Hannah Lavoie, BA    603-646-7040    behavior.change@dartmouth.edu   
Principal Investigator: Lisa A Marsch, PhD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Lisa A Marsch, PhD Dartmouth College
  Study Documents (Full-Text)

Documents provided by Lisa A. Marsch, Dartmouth-Hitchcock Medical Center:

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Responsible Party: Lisa A. Marsch, Andrew G. Wallace Professor; Director, Center for Technology and Behavioral Health, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03774433     History of Changes
Other Study ID Numbers: 4UH3DA041713-04 D19035
UH3DA041713 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After completion of the study, a de-identified dataset (i.e., stripped of all codes and other information that could be linked back to an individual participant) will be generated and made available to the research community as a whole. 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.
Time Frame: Data will be available upon submission of the paper detailing the findings of the research.
Access Criteria: All data will be shared openly with no restrictions on access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa A. Marsch, Dartmouth-Hitchcock Medical Center:
self-regulation
binge eating
smoking
ecological momentary assessment
mobile sensing
mHealth
Additional relevant MeSH terms:
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Bulimia
Binge-Eating Disorder
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders