跳至主要内容
临床试验/NCT03774433
NCT03774433已完成不适用

Applying Novel Technologies and Methods to Inform the Ontology of Self-Regulation - Aim 4 Dartmouth Study: Using Mobile Technology to Improve Self-Regulation

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2019年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
2
主要终点
Rate of Binge Eating Episodes [Binge Eating Sample Only]

研究概览

简要总结

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.

详细描述

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 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, the investigators 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. The investigators 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 across two phases of funding (UH2 and UH3 phases). Note that Aims 1-3 were conducted under our prior UH2 phase, and the investigators herein include the protocol for Aim 4 to be conducted in the UH3 phase:

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. The investigators will build on Multiple PI Poldrack's pioneering "Cognitive Atlas" ontology to integrate concepts across divergent literatures to develop an "ontology" of self-regulatory processes. The 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 putative targets can be engaged and manipulated 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. The investigators 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 Marsch) in which the investigators will leverage our novel mobile-based behavioral assessment/intervention platform to modulate target engagement and collect data in real-world conditions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Rate of Binge Eating Episodes [Binge Eating Sample Only]

时间窗: 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. 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.

Rate of Smoking Episodes [Smoking Sample Only]

时间窗: 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. 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lisa A. Marsch

Andrew G. Wallace Professor; Director, Center for Technology and Behavioral Health

Dartmouth-Hitchcock Medical Center

研究点 (2)

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