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=5 Participants	15.4 years STANDARD_DEVIATION 0.7 • n=7 Participants	15.3 years STANDARD_DEVIATION 0.7 • n=5 Participants
Sex: Female, Male Female	275 Participants n=5 Participants	268 Participants n=7 Participants	543 Participants n=5 Participants
Sex: Female, Male Male	229 Participants n=5 Participants	219 Participants n=7 Participants	448 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	451 Participants n=5 Participants	404 Participants n=7 Participants	855 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	83 Participants n=7 Participants	136 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	504 participants n=5 Participants	487 participants n=7 Participants	991 participants n=5 Participants
Yearly household income <$20,000	192 Participants n=5 Participants	206 Participants n=7 Participants	398 Participants n=5 Participants
Yearly household income $20,000-39,999	163 Participants n=5 Participants	126 Participants n=7 Participants	289 Participants n=5 Participants
Yearly household income >=$40,000	132 Participants n=5 Participants	137 Participants n=7 Participants	269 Participants n=5 Participants
Yearly household income Missing	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to two years

Population: 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	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.	Comparison n=206 Participants 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.
Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study	22 Participants	12 Participants

PRIMARY outcome

Timeframe: Baseline to two years

Change 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	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.	Comparison n=180 Participants 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.
Change in Physical Activity	-14.5 minutes Standard Deviation 31.3	-12.9 minutes Standard Deviation 30.7

PRIMARY outcome

Timeframe: Baseline to two years

Reported 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	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.	Comparison n=205 Participants 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.
Change in Reported Added Sugar Intake	-1.9 teaspoons Standard Deviation 7.8	-0.9 teaspoons Standard Deviation 6.2

PRIMARY outcome

Timeframe: Baseline to two years

Change 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	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.	Comparison n=205 Participants 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.
Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes)	-0.41 cups Standard Deviation 1.42	-0.32 cups Standard Deviation 1.46

PRIMARY outcome

Timeframe: Baseline to two years

Change 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	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.	Comparison n=131 Participants 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.
Change in BMI Z-score	0.018 standard deviation units Standard Deviation 0.302	-0.047 standard deviation units Standard Deviation 0.397

PRIMARY outcome

Timeframe: Baseline to two years

Change 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	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.	Comparison n=129 Participants 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.
Change in HOMA-IR	0.613 index score units Standard Deviation 5.842	-0.236 index score units Standard Deviation 2.976

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

Alberta Kong

University of New Mexico Health Sciences

Phone: 505-272-5551

Email: AKong@salud.unm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place