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Clinical Trials/NCT02502383
NCT02502383
Completed
Not Applicable

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

University of New Mexico1 site in 1 country991 target enrollmentFebruary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Overweight
Sponsor
University of New Mexico
Enrollment
991
Locations
1
Primary Endpoint
Change in Reported Added Sugar Intake
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2014
End Date
November 29, 2017
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alberta Kong, MD, MPH

Professor

University of New Mexico

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

Outcomes

Primary Outcomes

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

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

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.

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.

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

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

Study Sites (1)

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