Trial Outcomes & Findings for Wellness Achieved Through Changing Habits (The WATCH Study) (NCT NCT03284788)
NCT ID: NCT03284788
Last Updated: 2023-10-05
Results Overview
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.
COMPLETED
NA
17 participants
Baseline; Week 8
2023-10-05
Participant Flow
Participants were recruited in clinics or through social media.
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.
Participant milestones
| Measure |
ABT Intervention
Participants attended 15, 90-minute sessions via videoconferencing software. They also met with a registered dietitian at baseline.
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|---|---|
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Overall Study
STARTED
|
13
|
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Overall Study
COMPLETED
|
11
|
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Overall Study
NOT COMPLETED
|
2
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Reasons for withdrawal
| Measure |
ABT Intervention
Participants attended 15, 90-minute sessions via videoconferencing software. They also met with a registered dietitian at baseline.
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|---|---|
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Wellness Achieved Through Changing Habits (The WATCH Study)
Baseline characteristics by cohort
| Measure |
ABT Intervention
n=13 Participants
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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|---|---|
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Age, Continuous
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16.69 years
STANDARD_DEVIATION 1.65 • n=99 Participants
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Sex: Female, Male
Female
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13 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latina
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2 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Not Hispanic/Latina
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
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5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
1 Participants
n=99 Participants
|
|
Highest parental education
High school diploma/GED
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2 Participants
n=99 Participants
|
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Highest parental education
Some college/associate degree
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3 Participants
n=99 Participants
|
|
Highest parental education
College graduate
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3 Participants
n=99 Participants
|
|
Highest parental education
Graduate or professional degree
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4 Participants
n=99 Participants
|
|
Highest parental education
Unknown
|
1 Participants
n=99 Participants
|
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Body Mass Index (BMI)
|
35.28 kg/m^2
STANDARD_DEVIATION 5.50 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 8Population: 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.
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.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=60 Participants
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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|---|---|
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Number of Participants Recruited
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16 Participants
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PRIMARY outcome
Timeframe: Baseline; Month 6Population: 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.
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.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=13 Participants
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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|---|---|
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Percentage of Participants Who Did Not Complete the Intervention.
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15.4 percentage of participants
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PRIMARY outcome
Timeframe: Baseline; Week 1Population: 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.
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.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=16 Participants
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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|---|---|
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Percentage of Participants Who Decide to Participate in the Intervention
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81.3 percentage of participants
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PRIMARY outcome
Timeframe: Week 1; Week 24Population: 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
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.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=11 Participants
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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|---|---|
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Percentage of Participants Who Attend All Intervention Sessions.
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90.9 percentage of participants
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SECONDARY outcome
Timeframe: Baseline; Month 6Population: 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.
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.
Outcome measures
| Measure |
ABT Weight Loss Intervention
n=11 Participants
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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|---|---|
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Change in BMI Z-score
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-0.15 z-scores
Standard Deviation 0.34
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Adverse Events
ABT Weight Loss Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place