Clinical trial NCT02502383: ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Official title: ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Adolescent
Overweight
Obesity
Weight loss
Nutrition
Physical Activity
School-based
Primary care
Motivational Interviewing
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 991
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study
timeFrame: Baseline to two years
measure: Change in Physical Activity
timeFrame: Baseline to two years
measure: Change in Reported Added Sugar Intake
timeFrame: Baseline to two years
measure: Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes)
timeFrame: Baseline to two years
measure: Change in BMI Z-score
timeFrame: Baseline to two years
measure: Change in HOMA-IR
timeFrame: Baseline to two years
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Alberta S Kong, MD, MPH
state: New Mexico
Study officials:
affiliation: UNM Health Sciences Center/Dept of Pediatrics
name: Alberta Kong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vallabhan MK, Kong AS, Jimenez EY, Summers LC, DeBlieck CJ, Feldstein Ewing SW. Training Primary Care Providers in the Use of Motivational Interviewing for Youth Behavior Change. Res Theory Nurs Pract. 2017 Aug 1;31(3):219-232. doi: 10.1891/1541-6577.31.3.219.
citation: Vallabhan MK, Jimenez EY, Nash JL, Gonzales-Pacheco D, Coakley KE, Noe SR, DeBlieck CJ, Summers LC, Feldstein-Ewing SW, Kong AS. Motivational Interviewing to Treat Adolescents With Obesity: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20180733. doi: 10.1542/peds.2018-0733. Epub 2018 Oct 22.
citation: Euler R, Jimenez EY, Sanders S, Kuhlemeier A, Van Horn ML, Cohen D, Gonzales-Pacheco D, Kong AS. Rural-Urban Differences in Baseline Dietary Intake and Physical Activity Levels of Adolescents. Prev Chronic Dis. 2019 Jan 3;16:E01. doi: 10.5888/pcd16.180200.
citation: Sanders SG, Jimenez EY, Cole NH, Kuhlemeier A, McCauley GL, Van Horn ML, Kong AS. Estimated Physical Activity in Adolescents by Wrist-Worn GENEActiv Accelerometers. J Phys Act Health. 2019 Sep 1;16(9):792-798. doi: 10.1123/jpah.2018-0344. Epub 2019 Jul 17.
citation: Kuhlemeier A, Jaki T, Jimenez EY, Kong AS, Gill H, Chang C, Resnicow K, Wilson DK, Van Horn ML. Individual differences in the effects of the ACTION-PAC intervention: an application of personalized medicine in the prevention and treatment of obesity. J Behav Med. 2022 Apr;45(2):211-226. doi: 10.1007/s10865-021-00274-2. Epub 2022 Jan 15.
citation: Hess JM, Jimenez EY, Ozechowski TJ, McCauley G, Sanders SG, Sedillo D, Vallabhan MK, Kong AS. Teen and caregiver perspectives on success, clinician role, and family involvement in ACTION PAC, a weight management intervention trial. PEC Innov. 2022 Dec;1:100060. doi: 10.1016/j.pecinn.2022.100060. Epub 2022 Jun 24.