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

June 3, 2024 updated by: Alberta Kong, MD, MPH, University of New Mexico
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

991

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Alberta S Kong, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Behavioral: Communication with parents
A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians.
Active Comparator: Comparison
Students attending comparison schools will receive communication of BMI and other health results to parents via a letter.
Behavioral: Communication with parents
A letter containing BMI and other health results and obesity prevention recommendations will be sent to parent/guardians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study
Time Frame: Baseline to two years
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
Time Frame: Baseline to two years
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
Time Frame: Baseline to two years
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)
Time Frame: Baseline to two years
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
Time Frame: Baseline to two years
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
Time Frame: Baseline to two years
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in BMI z score in those who are overweight/obese
Time Frame: Baseline to 2 years
Baseline to 2 years
Change in insulin resistance as measured by the homeostatic model assessment insulin resistance index
Time Frame: Baseline to 2 years
Baseline to 2 years
Change in minutes of moderate to vigorous physical activity by accelerometry
Time Frame: Baseline to 2 years
Baseline to 2 years
Change in dietary intake by use of a food screener questionnaire
Time Frame: Baseline to 2 years
Baseline to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Investigators

  • Principal Investigator: Alberta Kong, MD, MPH, UNM Health Sciences Center/Dept of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

November 29, 2017

Study Completion (Actual)

November 29, 2017

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimated)

July 20, 2015

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HL118734 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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