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

Not Applicable

Completed

Conditions: Overweight
Obesity

Interventions: Behavioral: ACTION PAC
Behavioral: Communication with parents

Registration Number: NCT02502383

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 991

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACTION PAC Behavioral Intervention	ACTION PAC	Students attending intervention schools will receive the ACTION PAC intervention and communication of BMI and other health results to parents via a letter.
ACTION PAC Behavioral Intervention	Communication with parents	Students attending intervention schools will receive the ACTION PAC intervention and communication of BMI and other health results to parents via a letter.
Comparison	Communication with parents	Students attending comparison schools will receive communication of BMI and other health results to parents via a letter.

Primary Outcome Measures

Name	Time	Method
Change in Reported Added Sugar Intake	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)	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	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	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	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	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