Trial Outcomes & Findings for ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity (NCT NCT02502383)
NCT ID: NCT02502383
Last Updated: 2024-06-26
Results Overview
Number and percentage of students who had a baseline BMI \<85th percentile who had a BMI\>= 85th percentile (overweight or obese) at endline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
991 participants
Primary outcome timeframe
Baseline to two years
Results posted on
2024-06-26
Participant Flow
Participants were enrolled from February 2014 to November 2015. Participants were recruited during general school registration events, the classes or practices of interested teachers, and lunch time.
Teens were excluded based on assessments at the baseline visit: blood pressure in the range of stage 2 hypertension or a score of ≥20 on the Eating Attitudes Test.
Unit of analysis: Schools
Participant milestones
| Measure |
ACTION PAC
School-based health center providers will use motivational interviewing to assist students with adopting strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI and other health results discussion with clinical providers. Adolescents with overweight/obesity will meet with providers for 16 sessions over 2 years. A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
Comparison
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
|---|---|---|
|
Overall Study
STARTED
|
504 4
|
487 4
|
|
Overall Study
Midpoint
|
410 4
|
391 4
|
|
Overall Study
COMPLETED
|
343 4
|
332 4
|
|
Overall Study
NOT COMPLETED
|
161 0
|
155 0
|
Reasons for withdrawal
| Measure |
ACTION PAC
School-based health center providers will use motivational interviewing to assist students with adopting strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI and other health results discussion with clinical providers. Adolescents with overweight/obesity will meet with providers for 16 sessions over 2 years. A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
Comparison
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
130
|
131
|
|
Overall Study
Withdrawal by Subject
|
31
|
24
|
Baseline Characteristics
ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Baseline characteristics by cohort
| Measure |
ACTION PAC
n=504 Participants
School-based health center providers will use motivational interviewing to assist students with adopting strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI and other health results discussion with clinical providers. Adolescents with overweight/obesity will meet with providers for 16 sessions over 2 years. A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians.
|
Comparison
n=487 Participants
A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians.
|
Total
n=991 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.3 years
STANDARD_DEVIATION 0.7 • n=99 Participants
|
15.4 years
STANDARD_DEVIATION 0.7 • n=107 Participants
|
15.3 years
STANDARD_DEVIATION 0.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
275 Participants
n=99 Participants
|
268 Participants
n=107 Participants
|
543 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
229 Participants
n=99 Participants
|
219 Participants
n=107 Participants
|
448 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
451 Participants
n=99 Participants
|
404 Participants
n=107 Participants
|
855 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
504 participants
n=99 Participants
|
487 participants
n=107 Participants
|
991 participants
n=206 Participants
|
|
Yearly household income
<$20,000
|
192 Participants
n=99 Participants
|
206 Participants
n=107 Participants
|
398 Participants
n=206 Participants
|
|
Yearly household income
$20,000-39,999
|
163 Participants
n=99 Participants
|
126 Participants
n=107 Participants
|
289 Participants
n=206 Participants
|
|
Yearly household income
>=$40,000
|
132 Participants
n=99 Participants
|
137 Participants
n=107 Participants
|
269 Participants
n=206 Participants
|
|
Yearly household income
Missing
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to two yearsPopulation: Students that had a baseline BMI \<85th percentile and who had endline data
Number and percentage of students who had a baseline BMI \<85th percentile who had a BMI\>= 85th percentile (overweight or obese) at endline
Outcome measures
| Measure |
Comparison
n=206 Participants
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
ACTION PAC
n=228 Participants
ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
|
|---|---|---|
|
Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study
|
12 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Baseline to two yearsChange in minutes of moderate-to-vigorous physical activity as measured by accelerometer for participants who had a baseline BMI \<85th percentile and endline data
Outcome measures
| Measure |
Comparison
n=180 Participants
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
ACTION PAC
n=200 Participants
ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
|
|---|---|---|
|
Change in Physical Activity
|
-12.9 minutes
Standard Deviation 30.7
|
-14.5 minutes
Standard Deviation 31.3
|
PRIMARY outcome
Timeframe: Baseline to two yearsReported change in added sugar intake as measured by the Block Kids Food Screener-Last Week for Ages 2-17 for students who had a baseline BMI \<85th percentile and endline data
Outcome measures
| Measure |
Comparison
n=205 Participants
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
ACTION PAC
n=227 Participants
ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
|
|---|---|---|
|
Change in Reported Added Sugar Intake
|
-0.9 teaspoons
Standard Deviation 6.2
|
-1.9 teaspoons
Standard Deviation 7.8
|
PRIMARY outcome
Timeframe: Baseline to two yearsChange in reported fruit, vegetables, and legume intake (not including potatoes) for students who had a baseline BMI \<85th percentile and endline data
Outcome measures
| Measure |
Comparison
n=205 Participants
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
ACTION PAC
n=227 Participants
ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
|
|---|---|---|
|
Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes)
|
-0.32 cups
Standard Deviation 1.46
|
-0.41 cups
Standard Deviation 1.42
|
PRIMARY outcome
Timeframe: Baseline to two yearsChange in body-mass index (BMI; weight in kilograms divided by the square of the body height in meters) Z-score for students who had a baseline BMI \>= 85th percentile (overweight or obese) and endline data. A Z-score of 0 represents the population mean. A Z-score above 2 indicates obesity (BMI \>2 standard deviations above the mean) in children and teens. A decline in BMI Z-score would be a positive outcome in this weight management study.
Outcome measures
| Measure |
Comparison
n=131 Participants
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
ACTION PAC
n=119 Participants
ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
|
|---|---|---|
|
Change in BMI Z-score
|
-0.047 standard deviation units
Standard Deviation 0.397
|
0.018 standard deviation units
Standard Deviation 0.302
|
PRIMARY outcome
Timeframe: Baseline to two yearsChange in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR; insulin resistance index) for students who had a baseline BMI \>= 85th percentile (overweight or obese) and endline data. HOMA-IR is calculated using the formula: (fasting glucose \[mg/dL\] x fasting insulin \[microU/mL\])/405. HOMA-IR values \>2 indicate insulin resistance. A decrease in HOMA-IR would be a positive outcome.
Outcome measures
| Measure |
Comparison
n=129 Participants
A letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
ACTION PAC
n=116 Participants
ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
|
|---|---|---|
|
Change in HOMA-IR
|
-0.236 index score units
Standard Deviation 2.976
|
0.613 index score units
Standard Deviation 5.842
|
Adverse Events
ACTION PAC
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Comparison
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACTION PAC
n=504 participants at risk
ACTION PAC: Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
|
Comparison
n=487 participants at risk
Comparison: Annual BMI results will not be discussed with participants in comparison schools; however, a letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
|
|---|---|---|
|
General disorders
Hospitalization
|
3.0%
15/504 • Number of events 15 • 2 years
|
2.9%
14/487 • Number of events 14 • 2 years
|
|
Psychiatric disorders
Met criteria for eating disorder (anorexia, bulimia)
|
0.60%
3/504 • Number of events 3 • 2 years
|
0.00%
0/487 • 2 years
|
|
Cardiac disorders
Development of hypertension
|
0.20%
1/504 • Number of events 1 • 2 years
|
0.21%
1/487 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place