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OverweightACTION PACNCT02502383

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

A study testing ACTION PAC and Communication with parents in people with Overweight and Obesity, run by University of New Mexico at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Overweight, Obesity
What is being tested?
ACTION PAC and Communication with parents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
991 participants
Where
1 siteUnited States
Study dates
1 Feb 2014to 29 Nov 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Alberta S Kong, MD, MPH

    Albuquerque, New Mexico, 87131

Other trials in United States

About this study

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
Being tested
ACTION PAC, Communication with parents
Keywords
Adolescent, Overweight, Obesity, Weight loss, Nutrition, Physical Activity, School-based, Primary care, Motivational Interviewing
Medical subject headings
Overweight, Obesity, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACTION PACBehavioural

    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 parentsBehavioural

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

Study groups in NCT02502383
Study groupRoleWhat they receive
ACTION PAC Behavioral InterventionExperimentalStudents attending intervention schools will receive the ACTION PAC intervention and communication of BMI and other health results to parents via a letter.
Receives: Behavioral: ACTION PAC; Behavioral: Communication with parents
ComparisonActive comparatorStudents attending comparison schools will receive communication of BMI and other health results to parents via a letter.
Receives: Behavioral: Communication with parents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to two years

  2. 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

    Measured: Baseline to two years

  3. 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

    Measured: Baseline to two years

  4. 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

    Measured: Baseline to two years

  5. 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.

    Measured: Baseline to two years

  6. 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.

    Measured: Baseline to two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2015 (estimated)
  2. Study start1 Feb 2014
  3. Primary completion29 Nov 2017
  4. Study completion29 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02502383
Sponsor's protocol ID
R01HL118734
Acronym
ACTION PAC
Status last verified
Jun 2024
First submitted
14 Jul 2015
Last updated
26 Jun 2024
Data monitoring committee
No

Publications

  • 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.

    PubMed 28793946

  • 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.

    PubMed 30348753

  • 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.

    PubMed 30605423

  • 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.

    PubMed 31310994

  • 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.

    PubMed 35032253

  • 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.

    PubMed 36643597

Questions about this trial

What is this clinical trial studying?

A study testing ACTION PAC and Communication with parents in people with Overweight and Obesity, run by University of New Mexico at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02502383, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.

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