N/A
N=991
ACTION PAC: Adolescents Committed to Improvement of Nutrition & Physical Activity
Overweight · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02502383 ↗Enrolled (actual)
991
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study — 22; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACTION PAC (Behavioral); Communication with parents (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Proportion of Participants With Baseline BMI <85th Percentile Who Developed Overweight or Obesity by the End of the Study |
22; 12 | — |
| PRIMARY Change in Physical Activity |
-14.5; -12.9 | — |
| PRIMARY Change in Reported Added Sugar Intake |
-1.9; -0.9 | — |
| PRIMARY Change in Reported Fruit, Vegetables, and Legume Intake (Not Including Potatoes) |
-0.41; -0.32 | — |
| PRIMARY Change in BMI Z-score |
0.018; -0.047 | — |
| PRIMARY Change in HOMA-IR |
0.613; -0.236 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02502383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.