Trial Outcomes & Findings for A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity (NCT NCT04484831)
NCT ID: NCT04484831
Last Updated: 2023-10-12
Results Overview
Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
Baseline; Month 6
Results posted on
2023-10-12
Participant Flow
43 participants completed the informed consent process. 40 continued on to randomization and baseline measurements.
Participant milestones
| Measure |
ABT Weight Loss Intervention
Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
ABT Weight Loss Intervention: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
|
Enhanced Care
Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
Enhanced Care: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
ABT Weight Loss Intervention
Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
ABT Weight Loss Intervention: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
|
Enhanced Care
Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
Enhanced Care: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Information provided details the mean age of the combined sample, the intervention group, and the control group.
Baseline characteristics by cohort
| Measure |
ABT Weight Loss Intervention
n=20 Participants
Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
ABT Weight Loss Intervention: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
|
Enhanced Care
n=20 Participants
Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
Enhanced Care: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.50 Years
STANDARD_DEVIATION 1.54 • n=93 Participants • Information provided details the mean age of the combined sample, the intervention group, and the control group.
|
16.05 Years
STANDARD_DEVIATION 1.54 • n=4 Participants • Information provided details the mean age of the combined sample, the intervention group, and the control group.
|
15.78 Years
STANDARD_DEVIATION 1.54 • n=27 Participants • Information provided details the mean age of the combined sample, the intervention group, and the control group.
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race
White
|
14 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Race
Black
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race
Other
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Highest Parental Education
Some High School/High School Diploma/GED
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Highest Parental Education
Some college/Associate degree
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Highest Parental Education
Completed Tech or Vocational School/College Graduate
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Highest Parental Education
Graduate or professional degree
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
BMI
|
32.66 kg/m^2
STANDARD_DEVIATION 5.53 • n=93 Participants
|
34.68 kg/m^2
STANDARD_DEVIATION 7.73 • n=4 Participants
|
33.67 kg/m^2
STANDARD_DEVIATION 6.71 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline; Month 6Changes in weight relative to the BMI at the 95th percentile based on sex-and-age (as a difference in percentage units and/or a difference in BMI units) will be evaluated.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=19 Participants
Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
ABT Weight Loss Intervention: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
|
Enhanced Care
n=20 Participants
Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
Enhanced Care: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
|
|---|---|---|
|
BMI Change, 95th BMI Percentile (%)
|
-1.11 Change in the 95th BMI percentile %
Standard Deviation 5.93
|
-0.08 Change in the 95th BMI percentile %
Standard Deviation 8.05
|
SECONDARY outcome
Timeframe: Baseline; Month 6Measurements of quality of life (using the valid Pediatric Quality of Life Inventory assessment: scores 0-100) will be conducted. Higher scores indicate better health-related quality of life.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=19 Participants
Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
ABT Weight Loss Intervention: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
|
Enhanced Care
n=20 Participants
Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
Enhanced Care: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
|
|---|---|---|
|
Change in Quality of Life
|
2.94 score on a scale
Standard Error 10.86
|
3.12 score on a scale
Standard Error 11.15
|
SECONDARY outcome
Timeframe: Baseline; Month 6Depression is measured with the Beck Depression Inventory- II (BDI-II). The BDI-II measures the severity of depression. Each item is assessed on a 4-point ordinal categorical scale (0-3 points) that is specific to the question subject matter being addressed (e.g. sadness, self-criticalness, loss of pleasure, etc), and then answer choices are summed to generate a total score. The BDI-II is reliable and valid in an adolescent population. Participants receive a sum-score (ranging from 0-63), which correlates with a certain classification and level of depression. Scores 1-10 (normal ups and downs) and 11-16 (mild mood disturbance) are classified as low. Scores 17-20 (borderline clinical depression) and 21-30 (moderate depression) are classified as moderate. Scores 31-40 (severe depression) and 40+ (extreme depression) are classified as significant.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=19 Participants
Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
ABT Weight Loss Intervention: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
|
Enhanced Care
n=20 Participants
Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
Enhanced Care: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
|
|---|---|---|
|
Change in Depression Using the Valid Beck Depression Inventory-II
|
-2.81 score on a scale
Standard Deviation 11.58
|
0.71 score on a scale
Standard Deviation 12.26
|
SECONDARY outcome
Timeframe: Baseline; Month 6Measurements of anxiety-sensitivity (using the valid Short Scale Anxiety Sensitivity Index-3 assessment: scores 0-20) will be conducted. Higher scores indicate higher anxiety-sensitivity.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=19 Participants
Adolescent participants will attend sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
ABT Weight Loss Intervention: This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
|
Enhanced Care
n=20 Participants
Adolescent participants will receive handouts on elements of a healthy lifestyle and will participate in a midpoint one-on-one nutrition consultation with a registered dietitian.
Enhanced Care: This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
|
|---|---|---|
|
Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment
|
1.00 score on a scale
Standard Deviation 3.65
|
1.00 score on a scale
Standard Deviation 5.63
|
Adverse Events
ABT Weight Loss Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michelle Cardel, Adjunct Professor
University of Florida
Phone: 352-273-8811
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place