NCT00462267

Brief Summary

This project will examine the effectiveness of a primary care based intervention to help overweight teen girls adopt healthy lifestyle practices. Participants will be adolescent females from Kaiser Permanente Northwest primary care clinics with a body mass index above the 90th percentile. Teens will be randomly assigned to (1) a behavioral weight control program (enriched intervention), (2) brief primary care counseling (low intensity intervention), or (3) usual-care (control). For both of the project's active intervention arms, teens' primary care providers will be given customized plans describing the teen's eating and physical activity habits and instructions on how to best work with these teens and their families. The behavioral weight control program will be specifically tailored for teen girls and will include separate group meetings for teens and parents, follow-up telephone contacts with their group leader, and coordinated feedback from the teen's primary care provider.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2 obesity

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

January 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

4.9 years

First QC Date

April 17, 2007

Last Update Submit

April 2, 2015

Conditions

ObesityOverweight

Keywords

NutritionExerciseBody mass indexLifestyle changeObesityOverweightAdolescentsTeens

Outcome Measures

Primary Outcomes (1)

  • BMI z-score

    2 years

Secondary Outcomes (12)

  • Quality of life (PedsQL 4.0)

    2 years

  • Self esteem (RSE)

    2 years

  • Depression (PHQ-A)

    2 years

  • Unhealthy eating practices (QEWPR-A, TFEQ)

    2 years

  • Weight and shape concerns (WCS)

    2 years

  • +7 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

Enriched lifestyle intervention

EXPERIMENTAL
Behavioral: Enriched lifestyle intervention

Interventions

Enriched lifestyle interventionBEHAVIORAL

Multi-component lifestyle intervention

Enriched lifestyle intervention

Eligibility Criteria

Age13 Years - 15 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Body mass index 90th percentile or greater
  • One or both parent(s) willing to participate in study assessments and parent sessions

You may not qualify if:

  • Body mass index 99th percentile or greater
  • Significant cognitive impairment
  • Current pregnancy
  • Congenital heart disease that limits activity
  • Serious asthma requiring oral prednisone
  • Taking medications that increase appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lynn L DeBar, PhD, MPH

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

  • Michelle H Forest, PhD

    Kaiser Permanente

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 19, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

April 6, 2015

Record last verified: 2015-04

Locations

US(1)