Obesity, Overweight, Weight Loss
Conditions
Keywords
acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
Brief summary
The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.
Detailed description
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.
Interventions
BEHAVIORALABT 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.
OTHEREnhanced Care
This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
Sponsors
StayWell
National Heart, Lung, and Blood Institute (NHLBI)
WellCare Health Plans, Inc.
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts
Exclusion criteria
* Known pregnancy or plans to become pregnant in the next 2 years * Plans to move out of the area in the next year * Autism, any intellectual disability (e.g., down syndrome) * Any condition prohibiting physical activity * A diagnosis of cardiovascular disease or diabetes * Have active cancer or cancer requiring treatment in the past 2 years * Have active or chronic infections (e.g., HIV or TB) * Have active kidney disease or lung disease * An eating disorder or substance abuse disorder * Having recently begun a course of or changed the dosage of any medications known to affect appetite or body composition * Weight loss greater than or equal to 5% in the previous 6 months * If they do not follow the study plan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI Change, 95th BMI Percentile (%) | Baseline; Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline; Month 6 | 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. |
| Change in Depression Using the Valid Beck Depression Inventory-II | Baseline; Month 6 | 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. |
| Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment | Baseline; Month 6 | 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. |
Countries
United States
Participant flow
Recruitment details
43 participants completed the informed consent process. 40 continued on to randomization and baseline measurements.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | ABT Weight Loss Intervention | Enhanced Care | Total |
|---|---|---|---|
| Age, Continuous | 15.50 Years STANDARD_DEVIATION 1.54 | 16.05 Years STANDARD_DEVIATION 1.54 | 15.78 Years STANDARD_DEVIATION 1.54 |
| BMI | 32.66 kg/m^2 STANDARD_DEVIATION 5.53 | 34.68 kg/m^2 STANDARD_DEVIATION 7.73 | 33.67 kg/m^2 STANDARD_DEVIATION 6.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 17 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest Parental Education Completed Tech or Vocational School/College Graduate | 3 Participants | 5 Participants | 8 Participants |
| Highest Parental Education Graduate or professional degree | 10 Participants | 8 Participants | 18 Participants |
| Highest Parental Education Some college/Associate degree | 5 Participants | 4 Participants | 9 Participants |
| Highest Parental Education Some High School/High School Diploma/GED | 2 Participants | 3 Participants | 5 Participants |
| Race Black | 4 Participants | 2 Participants | 6 Participants |
| Race Other | 2 Participants | 1 Participants | 3 Participants |
| Race White | 14 Participants | 17 Participants | 31 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABT Weight Loss Intervention | BMI Change, 95th BMI Percentile (%) | -1.11 Change in the 95th BMI percentile % | Standard Deviation 5.93 |
| Enhanced Care | BMI Change, 95th BMI Percentile (%) | -0.08 Change in the 95th BMI percentile % | Standard Deviation 8.05 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABT Weight Loss Intervention | Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment | 1.00 score on a scale | Standard Deviation 3.65 |
| Enhanced Care | Change in Anxiety-sensitivity Using the Valid Short Scale Anxiety Sensitivity Index Assessment | 1.00 score on a scale | Standard Deviation 5.63 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABT Weight Loss Intervention | Change in Depression Using the Valid Beck Depression Inventory-II | -2.81 score on a scale | Standard Deviation 11.58 |
| Enhanced Care | Change in Depression Using the Valid Beck Depression Inventory-II | 0.71 score on a scale | Standard Deviation 12.26 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABT Weight Loss Intervention | Change in Quality of Life | 2.94 score on a scale | Standard Error 10.86 |
| Enhanced Care | Change in Quality of Life | 3.12 score on a scale | Standard Error 11.15 |