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

Obesity Clinical Trial

— ACTION PAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502383
• Other study ID #: R01HL118734
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: November 29, 2017

Study information

• Verified date: February 2020
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 992
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• 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
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.

Locations

Country	Name	City	State
United States	Alberta S Kong, MD, MPH	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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). pii: e20180733. doi: 10.1542/peds.2018-0733. Epub 2018 Oct 22. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of overweight/obesity by BMI percentile		2 years
Secondary	Change in BMI z score in those who are overweight/obese		Baseline to 2 years
Secondary	Change in insulin resistance as measured by the homeostatic model assessment insulin resistance index		Baseline to 2 years
Secondary	Change in minutes of moderate to vigorous physical activity by accelerometry		Baseline to 2 years
Secondary	Change in dietary intake by use of a food screener questionnaire		Baseline to 2 years