Adolescents Committed to Nutrition and Physical Activity

Obesity Clinical Trial

— ACTION  

Official title:

Adolescents Committed to Improvement of Nutrition and Physical Activity (ACTION)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841334
• Other study ID #: 08-013
• Secondary ID: 5R21HL092533-02
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Est. completion date: October 2012

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: October 2012
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Overweight

Intervention

Behavioral:
• ACTION
Overweight/obese adolescents enrolled in ACTION will meet with SBHC providers over a 6 month period in one school year. SBHC providers will use Motivational Enhancement Therapy to motivate overweight/obese adolescents to adopt strategies for improving nutrition and physical activity.
• Usual care
Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.

Locations

Country	Name	City	State
United States	University of New Mexio	Albuquerque	New Mexico

Sponsors (3)

Lead Sponsor	Collaborator
University of New Mexico	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI percentile		6 months
Secondary	Insulin resistance		6 months
Secondary	Lipids		6 months
Secondary	Dietary intake		6 months
Secondary	Blood pressure		6 months
Secondary	Physical activity		6 months