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

NCT ID: NCT02502383

Last Updated: 2024-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

991 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-01

Study Completion Date

2017-11-29

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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ACTION PAC Behavioral Intervention

Students attending intervention schools will receive the ACTION PAC intervention and communication of BMI and other health results to parents via a letter.

Group Type EXPERIMENTAL

ACTION PAC

Intervention Type BEHAVIORAL

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.

Communication with parents

Intervention Type BEHAVIORAL

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

Comparison

Students attending comparison schools will receive communication of BMI and other health results to parents via a letter.

Group Type ACTIVE_COMPARATOR

Communication with parents

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Communication with parents

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Alberta Kong, MD, MPH

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberta Kong, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNM Health Sciences Center/Dept of Pediatrics

Locations

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Alberta S Kong, MD, MPH

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28793946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30348753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30605423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31310994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35032253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36643597 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R01HL118734

Identifier Type: NIH

Identifier Source: org_study_id

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