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

NCT02502383 | Completed Results

• 1 other identifier: R01HL118734
• Study Type: interventional
• Target: 991
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study

  Number and percentage of students who had a baseline BMI \<85th percentile who had a BMI\>= 85th percentile (overweight or obese) at endline

  Baseline to two years

• Change in Physical Activity

  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

  Baseline to two years

• Change in Reported Added Sugar Intake

  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

  Baseline to two years

• Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes)

  Change in reported fruit, vegetables, and legume intake (not including potatoes) for students who had a baseline BMI \<85th percentile and endline data

  Baseline to two years

• 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.

  Baseline to two years

• Change in HOMA-IR

  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.

  Baseline to two years

Study Arms (2)

ACTION PAC Behavioral Intervention

EXPERIMENTAL

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

Behavioral: ACTION PAC; Behavioral: Communication with parents

Comparison

ACTIVE COMPARATOR

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

Behavioral: Communication with parents

Interventions

ACTION PAC 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.

ACTION PAC Behavioral Intervention

Communication with parents BEHAVIORAL

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

ACTION PAC Behavioral Intervention; Comparison

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

Alberta S Kong, MD, MPH

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (6)

• 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.

  PMID: 28793946 BACKGROUND

• 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.

  PMID: 30348753 BACKGROUND

• 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.

  PMID: 30605423 BACKGROUND

• 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.

  PMID: 31310994 BACKGROUND

• 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.

  PMID: 35032253 BACKGROUND

• 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.

  PMID: 36643597 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Results Point of Contact

• Title: Alberta Kong
• Organization: University of New Mexico Health Sciences

AKong@salud.unm.edu

505-272-5551

Study Officials

• Alberta Kong, MD, MPH

  UNM Health Sciences Center/Dept of Pediatrics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2015
• First Posted: July 20, 2015
• Study Start: February 1, 2014
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Locations

US (1)