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Adolescents Committed to Nutrition and Physical Activity (ACTION)
This study is ongoing, but not recruiting participants.
First Received: February 9, 2009   Last Updated: January 12, 2010   History of Changes
Sponsor: University of New Mexico
Collaborators: National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: University of New Mexico
ClinicalTrials.gov Identifier: NCT00841334
  Purpose

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 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.


Condition Intervention Phase
Overweight
Obesity
Insulin Resistance
 Behavioral: ACTION
Behavioral: Usual care
 Phase I
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Adolescents Committed to Improvement of Nutrition and Physical Activity (ACTION)

Resource links provided by NLM:

MedlinePlus related topics: Obesity Obesity in Children
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • BMI z-score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Dietary intake [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 149
Study Start Date: May 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ACTION
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.
2: Active Comparator
Usual care
Behavioral: Usual care
Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.

  Eligibility

Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841334

Locations
United States, New Mexico
University of New Mexio
Albuquerque, New Mexico, United States, 87131-0001
Sponsors and Collaborators
University of New Mexico
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Alberta S Kong, MD, MPH University of New Mexico
  More Information

No publications provided

Responsible Party: University of New Mexico ( Alberta Kong, Principal Investigator )
Study ID Numbers: 08-013, 5R21HL092533-02
Study First Received: February 9, 2009
Last Updated: January 12, 2010
ClinicalTrials.gov Identifier: NCT00841334     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Adolescent
Overweight
Obesity
Weight loss
Nutrition
 Physical activity
Community-based participatory research
School-based
Primary Care
Motivational interviewing

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Hyperinsulinism
Obesity
Metabolic Diseases
 Nutrition Disorders
Overnutrition
Overweight
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010



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