Adolescents Committed to Nutrition and Physical Activity (ACTION)

March 8, 2024 updated by: Alberta Kong, MD, MPH, University of New Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Usual care
Behavioral: Usual care
Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.
Experimental: 1
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI percentile
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 6 months
6 months
Lipids
Time Frame: 6 months
6 months
Insulin resistance
Time Frame: 6 months
6 months
Dietary intake
Time Frame: 6 months
6 months
Physical activity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Alberta S Kong, MD, MPH, University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 9, 2009

First Posted (Estimated)

February 11, 2009

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-013
  • 5R21HL092533-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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