ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02502383

Acronym

ACTION PAC

Enrollment

991

Registered

2015-07-20

Start date

2014-02-01

Completion date

2017-11-29

Last updated

2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Keywords

Adolescent, Overweight, Obesity, Weight loss, Nutrition, Physical Activity, School-based, Primary care, Motivational Interviewing

Brief summary

Using a previously created weight management program for adolescents, the intervention will be implemented through school-based health centers (SBHC) and will be delivered by SBHC providers trained in Motivational Interviewing. Students at intervention school sites will be compared to students at control school sites. All students will have baseline, 1 year, and 2 year follow-up to assess if students in the intervention school sites will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students at control school sites.

Interventions

BEHAVIORALACTION 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.

BEHAVIORALCommunication with parents

A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

13 Years to 20 Years

Healthy volunteers

Yes

Inclusion criteria

* enrolled in 9th or 10th grade at participating schools

Exclusion criteria

* blood pressure in the range of stage 2 hypertension * previously diagnosed type 1 or type 2 diabetes * use of corticosteroids, antipsychotics, metformin, antihypertensive medications, and medications used for dyslipidemia * inability to perform moderate to vigorous physical activity * not ambulatory * a score of 20 or more on Eating Attitudes Test (EAT)-26 screening measure * developmental disorders that affect weight or ability to understand the study procedures or counseling

Design outcomes

Primary

Measure	Time frame	Description
Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study	Baseline to two years	Number and percentage of students who had a baseline BMI \<85th percentile who had a BMI\>= 85th percentile (overweight or obese) at endline
Change in Physical Activity	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
Change in Reported Added Sugar Intake	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
Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes)	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
Change in BMI Z-score	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.
Change in HOMA-IR	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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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 and other health results and obesity prevention recommendations will be sent to parent/guardians.	504
Comparison A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians.	487
Total	991

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	130	131
Overall Study	Withdrawal by Subject	31	24

Baseline characteristics

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

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 504	0 / 487
other Total, other adverse events	19 / 504	15 / 487
serious Total, serious adverse events	0 / 504	0 / 487

Outcome results

Primary

Change in BMI Z-score

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.