Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity
1 other identifier
interventional
131
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
September 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2021
CompletedResults Posted
Study results publicly available
August 26, 2024
CompletedAugust 26, 2024
July 1, 2024
1.5 years
April 13, 2019
July 8, 2022
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Anxiety Sensitivity Index-3
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.
Baseline,1-week, 2-week and 1-month follow-up
Dutch Eating Behavior Questionnaire
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.
Baseline,1-week, 2-week and 1-month follow-up
Eating Expectancy Inventory
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.
Baseline,1-week, 2-week and 1-month follow-up
Exercise Self-Efficacy
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).
Baseline,1-week, 2-week and 1-month follow-up
Study Arms (2)
Anxiety Sensitivity Training
EXPERIMENTALThe Anxiety Sensitivity training (AST) will provide: (1) psychoeducation on anxiety sensitivity and its consequences, (2) psychoeducation on the relationship between anxiety sensitivity and obesity-related health behavior correlates, and (3) concrete, evidenced-based strategies to reduce anxiety sensitivity.
Health Control
PLACEBO COMPARATORThe Health Control (HC) will cover general health care, such as information on wearing sunscreen and regular attendance to doctor appointments. The HC will not provide any recommendations or education on mood, dietary, or physical habits.
Interventions
Computerized Single-Session Anxiety Sensitivity Reduction Program
Eligibility Criteria
You may qualify if:
- Have a body mass index of at least 30
- Endorse elevated anxiety sensitivity defined as an ASI-3 score of 17 or greater
You may not qualify if:
- Any anticipated matters that would interfere with participating in the study
- Not being fluent in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anxiety and Health Research Lab, Substance Use Treatment Clinic, University of Houston
Houston, Texas, 77204, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Brooke Kauffman
- Organization
- University of Houston
Study Officials
- PRINCIPAL INVESTIGATOR
Brooke Kauffman, MA
University of Houston
- PRINCIPAL INVESTIGATOR
Michael J Zvolensky, Ph.D.
University of Houston
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 13, 2019
First Posted
April 17, 2019
Study Start
September 16, 2019
Primary Completion
March 6, 2021
Study Completion
March 6, 2021
Last Updated
August 26, 2024
Results First Posted
August 26, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share