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

July 31, 2024 updated by: Brooke Kauffman, University of Houston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • Anxiety and Health Research Lab, Substance Use Treatment Clinic, University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Anxiety Sensitivity Training
The 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.
Other: Anxiety Sensitivity Training
Computerized Single-Session Anxiety Sensitivity Reduction Program
Placebo Comparator: Health Control
The 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.
Other: Health Control
Computerized Single-Session Health Information Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline,1-week, 2-week and 1-month follow-up
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.
Baseline,1-week, 2-week and 1-month follow-up
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.
Baseline,1-week, 2-week and 1-month follow-up
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).
Baseline,1-week, 2-week and 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brooke Kauffman, MA, University of Houston
  • Principal Investigator: Michael J Zvolensky, Ph.D., University of Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 6, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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