An interventional study of ABT Weight Loss Intervention and Enhanced Care in Weight Loss, Obesity and Overweight, sponsored by University of Florida. Completed at 1 site in United States. Open to female participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.
Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.
The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.
Post-treatment assessments will occur.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 43 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
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Exclusion Criteria:
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.
Behavioral: ABT Weight Loss Intervention
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.
Other: Enhanced Care
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.
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 (%)
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.
Time frame: Baseline; Month 6
Change in Quality of Life
Measurements 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.
Time frame: Baseline; Month 6
Change in Depression Using the Valid Beck Depression Inventory-II
Depression 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.
Time frame: Baseline; Month 6
Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment
Measurements 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.
Time frame: Baseline; Month 6
43 participants completed the informed consent process. 40 continued on to randomization and baseline measurements.
| Milestone | ABT Weight Loss Intervention | Enhanced Care |
|---|---|---|
| Started | 20 | 20 |
| Completed | 19 | 20 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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.
| Change in the 95th BMI percentile % | ABT Weight Loss Intervention | Enhanced Care |
|---|---|---|
| BMI Change, 95th BMI Percentile (%) | -1.11 ± 5.93 | -0.08 ± 8.05 |
Measurements 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.
| score on a scale | ABT Weight Loss Intervention | Enhanced Care |
|---|---|---|
| Change in Quality of Life | 2.94 ± 10.86 | 3.12 ± 11.15 |
Depression 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.
| score on a scale | ABT Weight Loss Intervention | Enhanced Care |
|---|---|---|
| Change in Depression Using the Valid Beck Depression Inventory-II | -2.81 ± 11.58 | 0.71 ± 12.26 |
Measurements 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.
| score on a scale | ABT Weight Loss Intervention | Enhanced Care |
|---|---|---|
| Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment | 1.00 ± 3.65 | 1.00 ± 5.63 |
Collected over from baseline through study completion (6-months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABT Weight Loss Intervention | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Enhanced Care | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(Years) | ABT Weight Loss Intervention | Enhanced Care | Total |
|---|---|---|---|
| Mean | 15.50 ± 1.54 | 16.05 ± 1.54 | 15.78 ± 1.54 |
| Sex: Female, Male(Participants) | ABT Weight Loss Intervention | Enhanced Care | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | ABT Weight Loss Intervention | Enhanced Care | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 19 | 17 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race(Participants) | ABT Weight Loss Intervention | Enhanced Care | Total |
|---|---|---|---|
| White | 14 | 17 | 31 |
| Black | 4 | 2 | 6 |
| Other | 2 | 1 | 3 |
| Highest Parental Education(Participants) | ABT Weight Loss Intervention | Enhanced Care | Total |
|---|---|---|---|
| Some High School/High School Diploma/GED | 2 | 3 | 5 |
| Some college/Associate degree | 5 | 4 | 9 |
| Completed Tech or Vocational School/College Graduate | 3 | 5 | 8 |
| Graduate or professional degree | 10 | 8 | 18 |
| BMI(kg/m^2) | ABT Weight Loss Intervention | Enhanced Care | Total |
|---|---|---|---|
| Mean | 32.66 ± 5.53 | 34.68 ± 7.73 | 33.67 ± 6.71 |
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