Adolescents Committed to Nutrition and Physical Activity

NCT ID: NCT00841334

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight Obesity Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

ACTION

Group Type EXPERIMENTAL

ACTION

Intervention Type BEHAVIORAL

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

Usual care

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.

Interventions

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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.

Intervention Type BEHAVIORAL

Usual care

Overweight/obese adolescents in the second arm will receive a well child check with usual anticipatory guidance.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Alberta Kong, MD, MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alberta S Kong, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexio

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24379526 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23984053 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23589771 (View on PubMed)

Other Identifiers

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5R21HL092533-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

08-013

Identifier Type: -

Identifier Source: org_study_id

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