Obesity, Overweight, Weight Loss
Conditions
Keywords
acceptance-based therapy, adolescents, weight, weight loss, obesity, overweight
Brief summary
The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.
Detailed description
Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention. The intervention will include 15 sessions over 6 months. A post-treatment visit 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.
Sponsors
StayWell
National Heart, Lung, and Blood Institute (NHLBI)
WellCare Health Plans, Inc.
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Adolescent girls between ages 14-19 with overweight or obesity 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 * 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 begun a course of or changed the dosage of any medications known to affect appetite or body composition within the previous 3 months * 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 |
|---|---|---|
| Number of Participants Recruited | Baseline; Week 8 | Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks. |
| Percentage of Participants Who Did Not Complete the Intervention. | Baseline; Month 6 | The attrition strategy will be deemed feasible if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention. |
| Percentage of Participants Who Decide to Participate in the Intervention | Baseline; Week 1 | Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed acceptable if at least 80% of enrolled participants decide to participate in the intervention. |
| Percentage of Participants Who Attend All Intervention Sessions. | Week 1; Week 24 | This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI Z-score | Baseline; Month 6 | Body mass index (BMI) z-scores are measures of weight adjusted for the height, age, and sex of the child. BMI z-scores correspond with growth chart percentiles. These scores are calculated with an external reference rather than internal references. In this study, the Centers for Disease Control and Prevention SAS program was used to calculate scores based on 2000 CDC growth charts. Additionally, a clinically significant change in BMI z-score was defined as greater than or equal to -0.15 as this decrease has shown improvements in one or more cardiovascular disease risk factor. The central z-score value is 0, representing the population mean, and standard deviations below the mean indicate better outcomes. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in clinics or through social media.
Pre-assignment details
60 participants were screened for eligibility. Of these 43 were excluded (n=12 did not meet inclusion criteria, 31 declined to participate). 17 participants consented; 16 completed the baseline visits. 13 decided to participate in the intervention.
Participants by arm
| Arm | Count |
|---|---|
| ABT Intervention Adolescent girls will attend healthy lifestyle 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | ABT Intervention |
|---|---|
| Age, Continuous | 16.69 years STANDARD_DEVIATION 1.65 |
| Body Mass Index (BMI) | 35.28 kg/m^2 STANDARD_DEVIATION 5.5 |
| Highest parental education College graduate | 3 Participants |
| Highest parental education Graduate or professional degree | 4 Participants |
| Highest parental education High school diploma/GED | 2 Participants |
| Highest parental education Some college/associate degree | 3 Participants |
| Highest parental education Unknown | 1 Participants |
| Race/Ethnicity, Customized Black | 5 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 2 Participants |
| Race/Ethnicity, Customized Multiple Races | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latina | 11 Participants |
| Race/Ethnicity, Customized White | 7 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Number of Participants Recruited
Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks.
Time frame: Baseline; Week 8
Population: 60 participants were screened for eligibility. 43 were excluded (12 did not meet eligibility criteria; 31 declined to participate). 17 consented and 16 completed initial baseline visits. 13 decided to participate in the intervention. 11 received the allocated intervention and 2 did not (dropped out due to time constraints). Demographic variables were assessed among intervention participants, explaining the discrepancies between the results and participant flow sections.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ABT Weight Loss Intervention | Number of Participants Recruited | 16 Participants |
Primary
Percentage of Participants Who Attend All Intervention Sessions.
This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions.
Time frame: Week 1; Week 24
Population: 17 participants consented; 16 participants completed the 2 initial baseline clinic visits. Of the 16 participants who completed baseline visits, 13 decided to participate in the intervention. Of the 13 participants who decided to participate in the intervention, 11 received the allocated intervention and 2 did not (dropped out due to time constraints). This explanation provides insight into discrepancies between the results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT Weight Loss Intervention | Percentage of Participants Who Attend All Intervention Sessions. | 90.9 percentage of participants |
Primary
Percentage of Participants Who Decide to Participate in the Intervention
Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed acceptable if at least 80% of enrolled participants decide to participate in the intervention.
Time frame: Baseline; Week 1
Population: 17 participants consented; 16 participants completed the 2 initial baseline visits. Of the 16 participants who completed baseline visits, 13 decided to participate in the intervention. Of the 13 participants who decided to participate in the intervention, 11 received the allocated intervention and 2 dropped out due to time constraints. This explanation provides insight to discrepancies between the results and participant flow.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT Weight Loss Intervention | Percentage of Participants Who Decide to Participate in the Intervention | 81.3 percentage of participants |
Primary
Percentage of Participants Who Did Not Complete the Intervention.
The attrition strategy will be deemed feasible if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention.
Time frame: Baseline; Month 6
Population: 17 participants consented; 16 participants completed the 2 initial baseline clinic visits. Of the 16 participants who completed baseline visits, 13 decided to participate in the intervention. 11 received the allocated intervention and 2 did not (dropped out due to time constraints). Demographic variables were assessed among intervention participants (n=13).This explanation provides insights to the discrepancies between the results and participant flow sections.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT Weight Loss Intervention | Percentage of Participants Who Did Not Complete the Intervention. | 15.4 percentage of participants |
Secondary
Change in BMI Z-score
Body mass index (BMI) z-scores are measures of weight adjusted for the height, age, and sex of the child. BMI z-scores correspond with growth chart percentiles. These scores are calculated with an external reference rather than internal references. In this study, the Centers for Disease Control and Prevention SAS program was used to calculate scores based on 2000 CDC growth charts. Additionally, a clinically significant change in BMI z-score was defined as greater than or equal to -0.15 as this decrease has shown improvements in one or more cardiovascular disease risk factor. The central z-score value is 0, representing the population mean, and standard deviations below the mean indicate better outcomes.
Time frame: Baseline; Month 6
Population: 17 participants consented; 16 participants completed the 2 initial baseline clinic visits. Of the 16 participants who completed baseline visits, 13 decided to participate in the intervention. Of the 13 participants who decided to participate in the intervention, 11 received the allocated intervention and 2 did not (dropped out due to time constraints). This explanation provides insight into any discrepancies between the participant flow and results sections.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABT Weight Loss Intervention | Change in BMI Z-score | -0.15 z-scores | Standard Deviation 0.34 |