This trial is active, not recruiting.

Conditions overweight, obesity
Treatments action pac, comparison
Sponsor University of New Mexico
Start date January 2014
End date December 2017
Trial size 992 participants
Trial identifier NCT02502383, NIH-1 R01 HL118734


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
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)
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 Outcomes

Incidence of overweight/obesity by BMI percentile
time frame: 2 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 13 years up to 20 years old.

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

Additional Information

Official title ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of New Mexico.