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Adolescents Committed to Nutrition and Physical Activity (ACTION)

Primary Purpose

Overweight, Obesity, Insulin Resistance

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ACTION
Usual care
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight focused on measuring Adolescent, Overweight, Obesity, Weight loss, Nutrition, Physical activity, Community-based participatory research, School-based, Primary Care, Motivational interviewing

Eligibility Criteria

13 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of New Mexio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

ACTION

Usual care

Outcomes

Primary Outcome Measures

BMI percentile

Secondary Outcome Measures

Insulin resistance
Lipids
Dietary intake
Blood pressure
Physical activity

Full Information

First Posted
February 9, 2009
Last Updated
January 22, 2013
Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00841334
Brief Title
Adolescents Committed to Nutrition and Physical Activity
Acronym
ACTION
Official Title
Adolescents Committed to Improvement of Nutrition and Physical Activity (ACTION)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Mexico
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Insulin Resistance
Keywords
Adolescent, Overweight, Obesity, Weight loss, Nutrition, Physical activity, Community-based participatory research, School-based, Primary Care, Motivational interviewing

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ACTION
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
ACTION
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.
Primary Outcome Measure Information:
Title
BMI percentile
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Insulin resistance
Time Frame
6 months
Title
Lipids
Time Frame
6 months
Title
Dietary intake
Time Frame
6 months
Title
Blood pressure
Time Frame
6 months
Title
Physical activity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberta S Kong, MD, MPH
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexio
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24379526
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.
Results Reference
derived
PubMed Identifier
23984053
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.
Results Reference
derived
PubMed Identifier
23589771
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.
Results Reference
derived

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Adolescents Committed to Nutrition and Physical Activity

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