Clinical trial NCT00841334: Adolescents Committed to Nutrition and Physical Activity
Official title: Adolescents Committed to Improvement of Nutrition and Physical Activity (ACTION)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Insulin Resistance
Keywords: Adolescent
Overweight
Obesity
Weight loss
Nutrition
Physical activity
Community-based participatory research
School-based
Primary Care
Motivational interviewing
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-02-11
Enrollment: 145
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Community based participatory research principles will be used to create, implement and evaluate a culturally relevant and age-appropriate obesity intervention for adolescents who are overweight or obese. The intervention will be implemented through school-based health centers (SBHC) and will include clinical encounters with SBHC providers, use of Motivational Enhancement Therapy to help overweight/obese adolescents adopt healthier behaviors, and use of a community advisory council to develop obesity risk reduction strategies that will be delivered by print and digital video disc (DVD) media. To test efficacy of the ACTION intervention, overweight/obese adolescents will be recruited to either the intervention condition or the usual care condition. Students will have pre- and post- intervention measurements to assess if adolescents in the intervention condition will have improved risk factor profile for metabolic syndrome, improved nutrition and increased physical activity when compared with students in the usual care condition.


Eligibility criteria: Inclusion Criteria:

* greater than or equal to the 85th percentile in BMI
* in 9th through 11th grades at participating schools

Exclusion Criteria:

* BMI greater than or equal to 40
* previously diagnosed type 1 or type 2 diabetes
* blood pressure in the range of stage 2 hypertension
* medications that significantly interfere with weight

Primary outcomes:
measure: BMI percentile
timeFrame: 6 months
Secondary outcomes:
measure: Insulin resistance
timeFrame: 6 months
measure: Lipids
timeFrame: 6 months
measure: Dietary intake
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexio
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Alberta S Kong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romaniuk D, Kimsa MW, Strzalka-Mrozik B, Kimsa MC, Kabiesz A, Romaniuk W, Mazurek U. Gene expression of IGF1, IGF1R, and IGFBP3 in epiretinal membranes of patients with proliferative diabetic retinopathy: preliminary study. Mediators Inflamm. 2013;2013:986217. doi: 10.1155/2013/986217. Epub 2013 Nov 28.
citation: Sussman AL, Montoya C, Werder O, Davis S, Wallerstein N, Kong AS. An adaptive CBPR approach to create weight management materials for a school-based health center intervention. J Obes. 2013;2013:978482. doi: 10.1155/2013/978482. Epub 2013 Jul 29.
citation: Kong AS, Sussman AL, Yahne C, Skipper BJ, Burge MR, Davis SM. School-based health center intervention improves body mass index in overweight and obese adolescents. J Obes. 2013;2013:575016. doi: 10.1155/2013/575016. Epub 2013 Mar 26.