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Clinical Trials/NCT03917901
NCT03917901
Completed
Not Applicable

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

University of Houston1 site in 1 country131 target enrollmentSeptember 16, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Houston
Enrollment
131
Locations
1
Primary Endpoint
Anxiety Sensitivity Index-3
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 16, 2019
End Date
March 6, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Brooke Kauffman

Principal Investigator

University of Houston

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Anxiety Sensitivity Index-3

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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