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Computer-Delivered Intervention for Obese Sedentary Individuals With Elevated Anxiety Sensitivity

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ClinicalTrials.gov Identifier: NCT03917901
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Brooke Kauffman, University of Houston

Tracking Information
First Submitted Date  ICMJE April 13, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date July 30, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
  • Dutch Eating Behavior Questionnaire [ Time Frame: Assess change from baseline to 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.
  • Eating Expectancy Inventory [ Time Frame: Assess change from baseline to 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 facets: eating helps manage negative affect; eating leads to feeling out of control; and eating alleviates boredom 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), 4-item eating leads to feeling out of control subscale (possible range 4 - 28), and 4-item eating alleviates boredom subscale (possible range 4 - 28) indicate better outcomes.
  • Food Cravings Questionnaire-State Version [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Food Cravings Questionnaire-State Version is a 15-item self-report measure used to assess the extent to which individuals experience food cravings. Participants are asked to rate on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) for each item. The Food Cravings Questionnaire-State Version assess five subscales each with 3-items including: (1) an intense desire to eat; (2) anticipation of positive reinforcement that may result from eating; (3) anticipation of relief from negative states and feelings as a result of eating; (4) obsessive preoccupation with food or lack of control over eating; and (5) craving as a physiological state. For the current study, the Food Cravings Questionnaire-State Version total score (all items summed) will be used as a measure of food cravings (possible range = 15 - 75) with lower scores indicating better outcomes.
  • Eating Disorder Diagnostic Scale [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Eating Disorder Diagnostic Scale is a 22-item questionnaire based on the DSM-IV diagnostic criteria for anorexia nervosa, bulimia nervosa, and binge eating disorder. For the current study, item 8 ("How many times per week on average over the past 3 months have you eaten an unusually large amount of food and experienced a loss of control?") will be used to assess binge eating frequency with lower scores indicating better outcomes (possible range = 0 - 14).
  • Decisional Balance Measure [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Decisional Balance Measure is a 16-item self-report measure that assesses perceived barriers/benefits to engage in exercise, in addition to the motivational and cognitive processes of behavior change for exercise. Items are rated on a 5- point Likert scale ranging from 1 (not important at all) to 5 (extremely important). The measure yields two factors, negative aspects of exercise (Cons: "At the end of the day, I am too exhausted to be physically active"), and positive aspects of exercise (Pros: "Regular exercise would help me have a more positive outlook on life"). Each subscale will be summed with lower scores on the 6-item Cons subscale indicate better outcomes (possible range = 6 -30) and higher scores on the Pros subscale indicate better outcomes (possible range = 10 -50).
  • Exercise Self-Efficacy [ Time Frame: Assess change from baseline to 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).
  • Mood and Anxiety Symptom Questionnaire Short Form [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Mood and Anxiety Symptom Questionnaire-Short Form will be used to assess anxiety/depressive symptoms. Participants indicate how much they have experienced each symptom on a 5-point Likert-type scale (1 = Not at all to 5 = Extremely). Specifically, the Anxious Arousal subscale will be used to measure anxiety and the Anhedonic Depression subscale will be used to measure depression. The Anxious Arousal subscale consists of 17-items that will be summed with lower scores indicating better outcomes (range = 17 - 85). The Anhedonic Depression subscale consists of 22-items that will be summed with lower scores indicating better outcomes (range = 22 - 110).
  • Anxiety Sensitivity Index-3 [ Time Frame: Assess change from baseline to 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.
  • Short-Form General Health Survey [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Short-Form General Health Survey is a 20-item questionnaire in which respondents indicate on a Likert scale their health status across five domains: physical functioning, role functioning, social functioning, mental health, and health perceptions. The physical health functioning subscale will be used in the current study and consists of 6 items related to limitations in a variety of physical activities, ranging from strenuous to basic, due to health. Items range from 1 (limited for more than 3 months) to 3 (not limited at all). Items are transformed to a 0 to 100 scale and averaged to create a score for the subscale. Higher scores reflect a better outcome (possible range 0 - 100).
  • Fatigue Severity Scale [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Fatigue Severity Scale (FSS) is a 9-item self-report measure of fatigue severity. Individuals are asked to indicate on a 7-point Likert-type scale ranging from 1 (strong disagreement) to 7 (strong agreement) which best fits each statement regarding fatigue within the last week. Items are summed for a total score with lower scores indicating a better outcome (possible range = 7-63).
Original Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Dutch Eating Behavior Questionnaire [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Dutch Eating Behavior Questionnaire will be used to assess emotional eating.
  • Eating Expectancy Inventory [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Eating Expectancy Inventory will be used to measure cognitive expectancies of eating.
  • Food Cravings Questionnaire-State Version [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Food Cravings Questionnaire-State Version will be used assess the extent to which individuals experience food cravings.
  • Eating Disorder Diagnostic Scale [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Eating Disorder Diagnostic Scale will be used to assess prevalence of eating disorders and behaviors.
  • Decisional Balance Measure [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Decisional Balance Measure will be used to assess perceived barriers and benefits to engage in exercise.
  • Exercise Self-Efficacy [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Exercise Self-Efficacy measure will be used to assess one's confidence about their ability to engage in physical activity.
  • Mood and Anxiety Symptom Questionnaire Short Form [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Mood and Anxiety Symptom Questionnaire Short Form will be used to assess anxiety and depressive symptoms.
  • Anxiety Sensitivity Index-3 [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Anxiety Sensitivity Index-3 will be used to assess sensitivity to, and fear of, the potential negative consequences of anxiety-related symptoms and sensations.
  • Short-Form General Health Survey [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Short-Form General Health Survey will be used to assess perceived physical health functioning.
  • Fatigue Severity Scale [ Time Frame: Assess change from baseline to 1-week, 2-week and 1-month follow-up ]
    The Fatigue Severity Scale will be used as a measure of fatigue severity.
Change History Complete list of historical versions of study NCT03917901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computer-Delivered Intervention for Obese Sedentary Individuals With Elevated Anxiety Sensitivity
Official Title  ICMJE Computer-Delivered Intervention for Obese Sedentary Individuals With Elevated Anxiety Sensitivity
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) phone-screener (pre-screener); (b) baseline appointment 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; (d) 2-week follow-up; (e) 1-month follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
If participant meets eligibility criteria, the participant will be randomly assigned to complete a one-session computer-delivered intervention: either (1) anxiety sensitivity reduction treatment or (2) health information control.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Anxiety Sensitivity
  • Eating
  • Physical Activity
Intervention  ICMJE
  • Other: Anxiety Sensitivity Training
    Computerized Single-Session Anxiety Sensitivity Reduction Program
  • Other: Health Control
    Computerized Single-Session Health Information Control
Study Arms  ICMJE
  • 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.
    Intervention: Other: Anxiety Sensitivity Training
  • 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.
    Intervention: Other: Health Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 16, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Be sedentary (moderate-intensity exercise less than twice a week for 30 minutes or less)

Exclusion Criteria:

  • Endorsement of current suicidal ideation, intent, or plan
  • Presence of psychosis
  • Any anticipated matters that would interfere with participating in the study
  • Not being fluent in English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Brooke Kauffman, MA 713-743-8056 bkauffma@central.uh.edu
Contact: Pamella Nizio, B.S 713-743-8056 niziopam@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03917901
Other Study ID Numbers  ICMJE STUDY00001405
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brooke Kauffman, University of Houston
Study Sponsor  ICMJE University of Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Brooke Kauffman, MA University of Houston
Principal Investigator: Michael J Zvolensky, Ph.D. University of Houston
PRS Account University of Houston
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP