Trial Outcomes & Findings for Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity (NCT NCT03917901)
NCT ID: NCT03917901
Last Updated: 2024-08-26
Results Overview
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.
COMPLETED
NA
131 participants
Baseline,1-week, 2-week and 1-month follow-up
2024-08-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
66
|
|
Overall Study
1-Week Follow-up
|
59
|
60
|
|
Overall Study
2-Week Follow-up
|
62
|
57
|
|
Overall Study
1-Month Follow-up
|
61
|
63
|
|
Overall Study
COMPLETED
|
65
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer-Delivered Intervention for Individuals With Obesity and Elevated Anxiety Sensitivity
Baseline characteristics by cohort
| Measure |
Anxiety Sensitivity Training
n=65 Participants
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
|
Health Control
n=66 Participants
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
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.06 years
STANDARD_DEVIATION 8.90 • n=99 Participants
|
31.83 years
STANDARD_DEVIATION 11.45 • n=107 Participants
|
30.95 years
STANDARD_DEVIATION 10.27 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
42 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
10 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=99 Participants
|
66 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Body Mass Index
|
38.11 kg/m^2
STANDARD_DEVIATION 5.98 • n=99 Participants
|
38.20 kg/m^2
STANDARD_DEVIATION 5.80 • n=107 Participants
|
38.15 kg/m^2
STANDARD_DEVIATION 5.87 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline,1-week, 2-week and 1-month follow-upPopulation: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
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.
Outcome measures
| Measure |
Anxiety Sensitivity Training
n=65 Participants
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
|
Health Control
n=66 Participants
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
|
|---|---|---|
|
Anxiety Sensitivity Index-3
Baseline
|
43.44 score on a scale
Standard Deviation 12.27
|
43.00 score on a scale
Standard Deviation 12.43
|
|
Anxiety Sensitivity Index-3
1-Week Follow-up
|
40.17 score on a scale
Standard Deviation 14.03
|
40.69 score on a scale
Standard Deviation 13.15
|
|
Anxiety Sensitivity Index-3
2-Week Follow-up
|
38.00 score on a scale
Standard Deviation 15.13
|
37.24 score on a scale
Standard Deviation 14.10
|
|
Anxiety Sensitivity Index-3
1-Month Follow-up
|
37.74 score on a scale
Standard Deviation 16.29
|
34.25 score on a scale
Standard Deviation 13.93
|
PRIMARY outcome
Timeframe: Baseline,1-week, 2-week and 1-month follow-upPopulation: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
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.
Outcome measures
| Measure |
Anxiety Sensitivity Training
n=65 Participants
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
|
Health Control
n=66 Participants
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
|
|---|---|---|
|
Dutch Eating Behavior Questionnaire
Baseline
|
3.58 score on a scale
Standard Deviation 0.91
|
3.68 score on a scale
Standard Deviation 0.87
|
|
Dutch Eating Behavior Questionnaire
1-Week Follow-up
|
3.54 score on a scale
Standard Deviation 1.03
|
3.59 score on a scale
Standard Deviation 0.92
|
|
Dutch Eating Behavior Questionnaire
2-Week Follow-up
|
3.31 score on a scale
Standard Deviation 1.08
|
3.52 score on a scale
Standard Deviation 0.94
|
|
Dutch Eating Behavior Questionnaire
1-Month Follow-up
|
3.21 score on a scale
Standard Deviation 1.15
|
3.35 score on a scale
Standard Deviation 0.98
|
PRIMARY outcome
Timeframe: Baseline,1-week, 2-week and 1-month follow-upPopulation: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
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.
Outcome measures
| Measure |
Anxiety Sensitivity Training
n=65 Participants
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
|
Health Control
n=66 Participants
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
|
|---|---|---|
|
Eating Expectancy Inventory
Baseline
|
88.17 score on a scale
Standard Deviation 22.11
|
90.06 score on a scale
Standard Deviation 20.69
|
|
Eating Expectancy Inventory
1-Week Follow-up
|
85.98 score on a scale
Standard Deviation 25.89
|
89.03 score on a scale
Standard Deviation 23.08
|
|
Eating Expectancy Inventory
2-Week Follow-up
|
82.19 score on a scale
Standard Deviation 26.18
|
88.30 score on a scale
Standard Deviation 23.15
|
|
Eating Expectancy Inventory
1-Month Follow-up
|
80.74 score on a scale
Standard Deviation 28.71
|
87.51 score on a scale
Standard Deviation 22.59
|
PRIMARY outcome
Timeframe: Baseline,1-week, 2-week and 1-month follow-upPopulation: Overall number is different from analyzed number due to participants not completing select follow-up assessments.
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).
Outcome measures
| Measure |
Anxiety Sensitivity Training
n=65 Participants
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
|
Health Control
n=66 Participants
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
|
|---|---|---|
|
Exercise Self-Efficacy
Baseline
|
14.11 score on a scale
Standard Deviation 9.31
|
16.59 score on a scale
Standard Deviation 8.13
|
|
Exercise Self-Efficacy
1-Week Follow-up
|
16.37 score on a scale
Standard Deviation 9.77
|
18.06 score on a scale
Standard Deviation 8.11
|
|
Exercise Self-Efficacy
2-Week Follow-up
|
15.52 score on a scale
Standard Deviation 9.14
|
17.54 score on a scale
Standard Deviation 8.48
|
|
Exercise Self-Efficacy
1-Month Follow-up
|
16.32 score on a scale
Standard Deviation 9.51
|
17.20 score on a scale
Standard Deviation 8.20
|
Adverse Events
Anxiety Sensitivity Training
Health Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place