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临床试验/NCT03917901
NCT03917901已完成不适用

Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity

University of Houston2 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2019年9月16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
131
试验地点
2
主要终点
Anxiety Sensitivity Index-3

研究概览

简要总结

The proposed study will design and evaluate a computerized-delivered single-session anxiety sensitivity reduction program (i.e., Anxiety Sensitivity Training; AST). The AST will be designed to achieve three primary aims: (1) provide psycho-educational information on AS and its consequences, (2) present psycho-educational information on the relationship between AS and obesity-related health behavior correlates, and (3) offer concrete, evidence-based strategies to facilitate motivation to change their obesity-related lifestyle behaviors.

详细描述

The primary goal of the research study is to investigate the efficacy of a brief, computer-delivered transdiagnostic intervention that addresses anxiety sensitivity to reduce emotional eating, eating expectancies, food cravings, binge eating, perceived barriers to engage in physical activity, anxiety/depressive symptoms, severity of daily fatigue and increase perceived benefits to engage in physical activity, exercise self-efficacy, willingness to use adaptive coping strategies, and perceived physical health functioning. To address this aim, the investigator's will implement a randomized controlled trial that will employ a longitudinal experimental design and involve five stages: (a) online pre-screener; (b) baseline survey consisting of a pre-intervention assessment (eligibility) and random assignment to a one-session computer-delivered intervention (Active versus Control); (c) 1-week follow-up survey; (d) 2-week follow-up survey; (e) 1-month follow-up survey.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Have a body mass index of at least 30
  • Endorse elevated anxiety sensitivity defined as an ASI-3 score of 17 or greater

排除标准

  • Any anticipated matters that would interfere with participating in the study
  • Not being fluent in English

结局指标

主要结局

Anxiety Sensitivity Index-3

时间窗: Baseline,1-week, 2-week and 1-month follow-up

The Anxiety Sensitivity Index-3 is an 18-item measured that will be used to assess sensitivity to, and fear of, the potential negative consequences of anxiety-related symptoms and sensations. Items are rated on a 5-point Likert scale, ranging from 0 (Very Little) to 4 (Very Much). Scores will be calculated by summing all items (possible range = 0 -72), with lower scores indicating a better outcome.

Dutch Eating Behavior Questionnaire

时间窗: Baseline,1-week, 2-week and 1-month follow-up

The Dutch Eating Behavior Questionnaire will be used to assess emotional eating. Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (very often). For the current study, the emotional eating subscale (13 items) will be used as a measure of emotional eating. The 13 items of the subscale are summed and divided by 13 to create a mean score with a range from 1-5. Lower scores on this measure indicate better outcomes.

Exercise Self-Efficacy

时间窗: Baseline,1-week, 2-week and 1-month follow-up

Exercise self-efficacy will be assessed with a 5-item self-report assessment of one's confidence about their ability to engage in physical activity. Items are rated on a 9-point Likert-type scale that ranges from 0 (not at all confident) to 8 (extremely confident). A total score will be created by summing the 5-items with higher scores indicating a better outcome (possible range 0 - 40).

Eating Expectancy Inventory

时间窗: Baseline,1-week, 2-week and 1-month follow-up

The Eating Expectancy Inventory will be used to measure cognitive expectancies of eating. The Eating Expectancy Inventory subscale facet: eating helps manage negative affect will be used in the current study. Respondents will be asked to rate on a 7-point Likert scale the degree to which they 1 (completely disagree) to 7 (completely agree) to each item. Responses are summed for each subscale. Lower scores on the 18-item eating helps manage negative affect subscale (possible range = 18 - 126) indicate better outcomes.

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

Brooke Kauffman

Principal Investigator

University of Houston

研究点 (2)

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