Anxiety Sensitivity, Eating, Obesity, Physical Activity
Conditions
Keywords
Anxiety Disorders, Depression, Anxiety Sensitivity, Obesity, Eating, Physical Activity, Exercise
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.
Interventions
OTHERAnxiety Sensitivity Training
Computerized Single-Session Anxiety Sensitivity Reduction Program
OTHERHealth Control
Computerized Single-Session Health Information Control
Sponsors
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Sensitivity Index-3 | 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 | 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. |
| Eating Expectancy Inventory | 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. |
| Exercise Self-Efficacy | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Anxiety Sensitivity Training: Computerized Single-Session Anxiety Sensitivity Reduction Program | 65 |
| 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.
Health Control: Computerized Single-Session Health Information Control | 66 |
| Total | 131 |
Baseline characteristics
| Characteristic | Anxiety Sensitivity Training | Health Control | Total |
|---|---|---|---|
| Age, Continuous | 30.06 years STANDARD_DEVIATION 8.9 | 31.83 years STANDARD_DEVIATION 11.45 | 30.95 years STANDARD_DEVIATION 10.27 |
| Body Mass Index | 38.11 kg/m^2 STANDARD_DEVIATION 5.98 | 38.20 kg/m^2 STANDARD_DEVIATION 5.8 | 38.15 kg/m^2 STANDARD_DEVIATION 5.87 |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Black or African American | 10 Participants | 16 Participants | 26 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Race White | 42 Participants | 38 Participants | 80 Participants |
| Region of Enrollment United States | 65 participants | 66 participants | 131 participants |
| Sex: Female, Male Female | 37 Participants | 43 Participants | 80 Participants |
| Sex: Female, Male Male | 28 Participants | 23 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 66 |
| other Total, other adverse events | 0 / 65 | 0 / 66 |
| serious Total, serious adverse events | 0 / 65 | 0 / 66 |
Outcome results
Primary
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.
Time frame: Baseline,1-week, 2-week and 1-month follow-up
Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxiety Sensitivity Training | Anxiety Sensitivity Index-3 | Baseline | 43.44 score on a scale | Standard Deviation 12.27 |
| Anxiety Sensitivity Training | Anxiety Sensitivity Index-3 | 1-Week Follow-up | 40.17 score on a scale | Standard Deviation 14.03 |
| Anxiety Sensitivity Training | Anxiety Sensitivity Index-3 | 2-Week Follow-up | 38.00 score on a scale | Standard Deviation 15.13 |
| Anxiety Sensitivity Training | Anxiety Sensitivity Index-3 | 1-Month Follow-up | 37.74 score on a scale | Standard Deviation 16.29 |
| Health Control | Anxiety Sensitivity Index-3 | 1-Month Follow-up | 34.25 score on a scale | Standard Deviation 13.93 |
| Health Control | Anxiety Sensitivity Index-3 | Baseline | 43.00 score on a scale | Standard Deviation 12.43 |
| Health Control | Anxiety Sensitivity Index-3 | 2-Week Follow-up | 37.24 score on a scale | Standard Deviation 14.1 |
| Health Control | Anxiety Sensitivity Index-3 | 1-Week Follow-up | 40.69 score on a scale | Standard Deviation 13.15 |
Primary
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.
Time frame: Baseline,1-week, 2-week and 1-month follow-up
Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxiety Sensitivity Training | Dutch Eating Behavior Questionnaire | 1-Week Follow-up | 3.54 score on a scale | Standard Deviation 1.03 |
| Anxiety Sensitivity Training | Dutch Eating Behavior Questionnaire | Baseline | 3.58 score on a scale | Standard Deviation 0.91 |
| Anxiety Sensitivity Training | Dutch Eating Behavior Questionnaire | 2-Week Follow-up | 3.31 score on a scale | Standard Deviation 1.08 |
| Anxiety Sensitivity Training | Dutch Eating Behavior Questionnaire | 1-Month Follow-up | 3.21 score on a scale | Standard Deviation 1.15 |
| Health Control | Dutch Eating Behavior Questionnaire | 1-Month Follow-up | 3.35 score on a scale | Standard Deviation 0.98 |
| Health Control | Dutch Eating Behavior Questionnaire | 1-Week Follow-up | 3.59 score on a scale | Standard Deviation 0.92 |
| Health Control | Dutch Eating Behavior Questionnaire | 2-Week Follow-up | 3.52 score on a scale | Standard Deviation 0.94 |
| Health Control | Dutch Eating Behavior Questionnaire | Baseline | 3.68 score on a scale | Standard Deviation 0.87 |
Primary
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.
Time frame: Baseline,1-week, 2-week and 1-month follow-up
Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxiety Sensitivity Training | Eating Expectancy Inventory | 1-Week Follow-up | 85.98 score on a scale | Standard Deviation 25.89 |
| Anxiety Sensitivity Training | Eating Expectancy Inventory | Baseline | 88.17 score on a scale | Standard Deviation 22.11 |
| Anxiety Sensitivity Training | Eating Expectancy Inventory | 2-Week Follow-up | 82.19 score on a scale | Standard Deviation 26.18 |
| Anxiety Sensitivity Training | Eating Expectancy Inventory | 1-Month Follow-up | 80.74 score on a scale | Standard Deviation 28.71 |
| Health Control | Eating Expectancy Inventory | 2-Week Follow-up | 88.30 score on a scale | Standard Deviation 23.15 |
| Health Control | Eating Expectancy Inventory | 1-Week Follow-up | 89.03 score on a scale | Standard Deviation 23.08 |
| Health Control | Eating Expectancy Inventory | 1-Month Follow-up | 87.51 score on a scale | Standard Deviation 22.59 |
| Health Control | Eating Expectancy Inventory | Baseline | 90.06 score on a scale | Standard Deviation 20.69 |
Primary
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).
Time frame: Baseline,1-week, 2-week and 1-month follow-up
Population: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Anxiety Sensitivity Training | Exercise Self-Efficacy | 1-Week Follow-up | 16.37 score on a scale | Standard Deviation 9.77 |
| Anxiety Sensitivity Training | Exercise Self-Efficacy | 2-Week Follow-up | 15.52 score on a scale | Standard Deviation 9.14 |
| Anxiety Sensitivity Training | Exercise Self-Efficacy | 1-Month Follow-up | 16.32 score on a scale | Standard Deviation 9.51 |
| Anxiety Sensitivity Training | Exercise Self-Efficacy | Baseline | 14.11 score on a scale | Standard Deviation 9.31 |
| Health Control | Exercise Self-Efficacy | Baseline | 16.59 score on a scale | Standard Deviation 8.13 |
| Health Control | Exercise Self-Efficacy | 1-Week Follow-up | 18.06 score on a scale | Standard Deviation 8.11 |
| Health Control | Exercise Self-Efficacy | 1-Month Follow-up | 17.20 score on a scale | Standard Deviation 8.2 |
| Health Control | Exercise Self-Efficacy | 2-Week Follow-up | 17.54 score on a scale | Standard Deviation 8.48 |