NCT00682188

Brief Summary

Overweight in adolescents has nearly tripled in the past two decades and has serious physical and psychosocial consequences, both during adolescence and into adulthood. School nurses have tremendous potential to prevent and treat overweight in this population, as over 95% of adolescents have contact with the school health system each year and school nurses have the credibility and skills to provide guidance regarding weight, diet and physical activity. The goals of the proposed exploratory study are to adapt an innovative, theory-based school nurse-delivered counseling intervention model used effectively for smoking cessation for the treatment of adolescent overweight, and test its feasibility and potential efficacy in reducing BMI, improving diet, increasing physical activity and decreasing sedentary behavior. If the results of this exploratory study prove promising, the efficacy of the intervention will be evaluated in a large scale randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

1.2 years

First QC Date

May 20, 2008

Last Update Submit

March 12, 2014

Conditions

OverweightObesity

Keywords

OverweightObesityAdolescentsYouthSchool healthRandomized controlled trialIntervention study

Outcome Measures

Primary Outcomes (1)

  • BMI

    3- and 6-month post baseline

Secondary Outcomes (1)

  • Adherence to self-management behaviors (diet, physical activity, and sedentary behavior)

    3- and 6-month post baseline

Study Arms (2)

CI

EXPERIMENTAL

Six 30-minute individual student-centered counseling sessions based on the 5A approach to assist adolescents in making changes in their diet and level of physical activity delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2)

Behavioral: Counseling Intervention

II

ACTIVE COMPARATOR

Six individual sessions with the school nurse over 2 months to check weight and behavior changes and provide a series of six pamphlets on weight and weight management

Behavioral: Information Intervention

Interventions

Counseling InterventionBEHAVIORAL

Six 30-minute individual student-centered counseling sessions based on the 5A approach to assist adolescents in making changes in their diet and level of physical activity delivered by school nurses over 2 months (weekly in month 1, biweekly in month 2)

CI
Information InterventionBEHAVIORAL

Six individual sessions with the school nurse over 2 months to check weight and behavioral changes and provide a series of six pamphlets on weight and weight management

II

Eligibility Criteria

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

You may qualify if:

  • enrolled in grades 9 through 12
  • BMI equal or greater than 85th percentile
  • able to understand and participate in study protocol
  • able to provide informed assent (adolescent) and consent (parent)
  • student and at least one parent English speaking

You may not qualify if:

  • unable/unwilling to provide informed assent (adolescent)and consent (parent)
  • planning to move out of the area within the next 6 months
  • medical condition that precludes adherence to study dietary recommendations
  • diagnosis of a serious psychiatric illness within the past 5 years
  • genetic or endocrine causes of obesity
  • developmental delay that would prevent participation in intervention or measurements
  • prescribed medications associated with weight gain
  • morbidly obese, defined as 300 pounds oe greater

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Counseling

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lori Pbert, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

US(1)