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

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ClinicalTrials.gov Identifier: NCT02502383
Recruitment Status : Active, not recruiting
First Posted : July 20, 2015
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Alberta Kong, MD, MPH, University of New Mexico

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.

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: ACTION PAC Behavioral: Comparison Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 992 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Study Start Date : January 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: ACTION PAC Behavioral: ACTION PAC
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.

Active Comparator: Comparison Behavioral: Comparison
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 Measures :
  1. Incidence of overweight/obesity by BMI percentile [ Time Frame: 2 years ]

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


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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 EAT-26 screening measure
  • developmental disorders that affect weight or ability to understand the study procedures or counseling

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502383


Locations
United States, New Mexico
Alberta S Kong, MD, MPH
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Alberta Kong, MD, MPH UNM Health Sciences Center/Dept of Pediatrics

Publications:
Responsible Party: Alberta Kong, MD, MPH, Associate Professor, University of New Mexico
ClinicalTrials.gov Identifier: NCT02502383     History of Changes
Other Study ID Numbers: NIH-1 R01 HL118734
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by Alberta Kong, MD, MPH, University of New Mexico:
Adolescent
Overweight
Obesity
Weight loss
Nutrition
Physical Activity
School-based
Primary care
Motivational Interviewing

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms