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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL141535 | U.S. NIH Grant/Contract | View source | |
| PA-16-190 | Other Grant/Funding Number | National Institute of Health |
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| Name | Class |
|---|---|
| StayWell | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| WellCare Health Plans, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT Weight Loss Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT Weight Loss Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; Week 8 |
| 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. | Baseline; Month 6 |
| 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. | Baseline; Week 1 |
| 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. | Week 1; Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle I Cardel, PhD, MS, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthStreet and University of Florida | Gainesville | Florida | 32608 | United States |
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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 were recruited in clinics or through social media.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT Intervention | Participants attended 15, 90-minute sessions via videoconferencing software. They also met with a registered dietitian at baseline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Baseline; Week 8 |
|
Adverse event data were collected over the course of baseline through study completion [6 months].
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT Weight Loss 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Cardel, Adjunct Professor | University of Florida | 352-273-8811 | mcardel@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2021 | Jul 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 13, 2019 | Jul 12, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D050177 | Overweight |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
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| Baseline; Month 6 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Highest parental education | Count of Participants | Participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
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| 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. | 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. | Posted | Number | percentage of participants | Baseline; Month 6 |
|
|
|
| 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. | 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. | Posted | Number | percentage of participants | Baseline; Week 1 |
|
|
|
| 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. | 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 | Posted | Number | percentage of participants | Week 1; Week 24 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | z-scores | Baseline; Month 6 |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |