NCT00841334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

February 9, 2009

Last Update Submit

March 8, 2024

Conditions

OverweightObesityInsulin Resistance

Keywords

AdolescentOverweightObesityWeight lossNutritionPhysical activityCommunity-based participatory researchSchool-basedPrimary CareMotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • BMI percentile

    6 months

Secondary Outcomes (5)

  • Insulin resistance

    6 months

  • Lipids

    6 months

  • Dietary intake

    6 months

  • Blood pressure

    6 months

  • Physical activity

    6 months

Study Arms (2)

1

EXPERIMENTAL

ACTION

Behavioral: ACTION

2

ACTIVE COMPARATOR

Usual care

Behavioral: Usual care

Interventions

ACTIONBEHAVIORAL

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.

1
Usual careBEHAVIORAL

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

2

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • greater than or equal to the 85th percentile in BMI
  • in 9th through 11th grades at participating schools

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexio

Albuquerque, New Mexico, 87131-0001, United States

Location

Related Publications (3)

  • 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.

    PMID: 24379526DERIVED

  • 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.

    PMID: 23984053DERIVED

  • 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.

    PMID: 23589771DERIVED

MeSH Terms

Conditions

OverweightObesityInsulin ResistanceWeight LossMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBody Weight ChangesBehavior

Study Officials

  • Alberta S Kong, MD, MPH

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2009

First Posted

February 11, 2009

Study Start

May 1, 2008

Primary Completion

May 1, 2010

Study Completion

October 1, 2012

Last Updated

March 12, 2024

Record last verified: 2024-03

Locations

US(1)