Using Mobile Technology to Improve Self-Regulation

NCT03774433 | Completed Results

• 2 other identifiers: 4UH3DA041713-04 D19035UH3DA041713
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-regulation; Binge Eating; Smoking

Keywords

self-regulation; binge eating; smoking; ecological momentary assessment; mobile sensing; mHealth

Outcome Measures

Primary Outcomes (2)

• Rate of Binge Eating Episodes [Binge Eating Sample Only]

  \[Binge eating sample only\] 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. We are reporting the mean and standard deviations of the target behavior for each sample by week (i.e., Week 1, Week 2, Week 3, and Week 4). Data were averaged for all assessments each week to calculate the number of binge-eating episodes per week.

  28 days

• Rate of Smoking Episodes [Smoking Sample Only]

  \[Smoking sample only\] 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. We are reporting the mean and standard deviations of the target behavior for each sample by week (i.e., Week 1, Week 2, Week 3, and Week 4). Data were averaged for all assessments each week to calculate the number of cigarettes smoked per week.

  28 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

Laddr BEHAVIORAL

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

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Compensatory behavior (e.g., purging, excessive exercise, fasting)
• o Already excluded as part of the DSM-5 binge eating disorder criteria

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for Technology and Behavioral Health, Dartmouth College

Lebanon, New Hampshire, 03766, United States

Location

Related Publications (1)

• Plaitano EG, McNeish D, Bartels SM, Bell K, Dallery J, Grabinski M, Kiernan M, Lavoie HA, Lemley SM, Lowe MR, MacKinnon DP, Metcalf SA, Onken L, Prochaska JJ, Sand CL, Scherer EA, Stoeckel LE, Xie H, Marsch LA. Adherence to a digital therapeutic mediates the relationship between momentary self-regulation and health risk behaviors. Front Digit Health. 2025 Feb 4;7:1467772. doi: 10.3389/fdgth.2025.1467772. eCollection 2025.

  PMID: 39981105 DERIVED

MeSH Terms

Conditions

Self-Control; Bulimia; Smoking

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Lisa Marsch
• Organization: Dartmouth College

Lisa.A.Marsch@dartmouth.edu

603-646-7092

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: December 11, 2018
• First Posted: December 13, 2018
• Study Start: February 27, 2019
• Primary Completion: June 29, 2020
• Study Completion: June 29, 2020
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)