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

Primary Purpose

Overweight, Obesity

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

ACTION PAC

Comparison

About this trial

This is an interventional prevention trial for Overweight focused on measuring Adolescent, Overweight, Obesity, Weight loss, Nutrition, Physical Activity, School-based, Primary care, Motivational Interviewing

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Alberta S Kong, MD, MPH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ACTION PAC

Comparison

Arm Description

Outcomes

Primary Outcome Measures

Incidence of overweight/obesity by BMI percentile

Secondary Outcome Measures

Change in BMI z score in those who are overweight/obese

Change in insulin resistance as measured by the homeostatic model assessment insulin resistance index

Change in minutes of moderate to vigorous physical activity by accelerometry

Change in dietary intake by use of a food screener questionnaire

Full Information

NCT ID

NCT02502383

First Posted

July 14, 2015

Last Updated

November 5, 2020

Sponsor

University of New Mexico

1. Study Identification

Unique Protocol Identification Number

NCT02502383

Brief Title

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

Acronym

ACTION PAC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 2014 (undefined)

Primary Completion Date

November 29, 2017 (Actual)

Study Completion Date

November 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of New Mexico

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight, Obesity

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

992 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACTION PAC

Arm Type

Experimental

Arm Title

Comparison

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

ACTION PAC

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Comparison

Intervention Description

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.

Primary Outcome Measure Information:

Title

Incidence of overweight/obesity by BMI percentile

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Change in BMI z score in those who are overweight/obese

Time Frame

Baseline to 2 years

Title

Change in insulin resistance as measured by the homeostatic model assessment insulin resistance index

Time Frame

Baseline to 2 years

Title

Change in minutes of moderate to vigorous physical activity by accelerometry

Time Frame

Baseline to 2 years

Title

Change in dietary intake by use of a food screener questionnaire

Time Frame

Baseline to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alberta Kong, MD, MPH

Organizational Affiliation

UNM Health Sciences Center/Dept of Pediatrics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alberta S Kong, MD, MPH

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28793946

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.

Results Reference

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PubMed Identifier

30348753

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.

Results Reference

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PubMed Identifier

30605423

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.

Results Reference

background

PubMed Identifier

31310994

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.

Results Reference

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

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