NCT01068236

Brief Summary

This project will examine the effectiveness of a primary care based intervention to help overweight teen girls adopt healthy lifestyle practices. Participants are adolescent females at select 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), (or 2) usual-care (control). Primary care providers of teens in the intervention condition are 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 is specifically tailored for teen girls and includes 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

100
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 Aug 2005

Longer than P75 for phase_2 obesity

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

August 1, 2005

Completed
4.3 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
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

4.3 years

First QC Date

February 11, 2010

Last Update Submit

March 23, 2010

Conditions

Obesity

Keywords

Teen girlsweightlosshealthy lifestyleyogaWeight loss and healthy lifestyle

Outcome Measures

Primary Outcomes (1)

  • BMI z-score

    2 years

Secondary Outcomes (3)

  • Blood pressure

    One year

  • Fasting lipid profile

    One year

  • Fasting glucose

    One year

Study Arms (2)

Healthy lifestyle intervention

EXPERIMENTAL

lifestyle/weight-loss intervention for overweight (95th - 99th percentile) female adolescents (13-15 years of age at study entry) to a usual-care control condition. The intervention will be 20-sessions and combines group visits, individual telephone coaching calls, and tailored pediatric primary care providers (PCP) visits.

Behavioral: Healthy lifestyle managment

Usual care

NO INTERVENTION

In the usual care control condition adolescents and their family will receive individualized feedback from the assessments as well as handouts outlining healthy means of maintaining / reducing weight for adolescents through improving nutrition and physical activity. In addition, these participants will be encouraged to seek any appropriate health care/education services available through Kaiser Permanente or in the community.

Interventions

Healthy lifestyle managmentBEHAVIORAL

Exercise, yoga, food diaries, provider consultation

Healthy lifestyle intervention

Eligibility Criteria

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

You may qualify if:

  • Females,
  • Ages 13- 15 at study recruitment,
  • BMI in overweight range (95th percentile - 99th percentile,
  • One or both parent(s) willing to participate.

You may not qualify if:

  • BMI \> 99th percentile,
  • 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

Related Publications (1)

  • DeBar LL, Stevens VJ, Perrin N, Wu P, Pearson J, Yarborough BJ, Dickerson J, Lynch F. A primary care-based, multicomponent lifestyle intervention for overweight adolescent females. Pediatrics. 2012 Mar;129(3):e611-20. doi: 10.1542/peds.2011-0863. Epub 2012 Feb 13.

    PMID: 22331335DERIVED

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Victor J Stevens, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

August 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 24, 2010

Record last verified: 2010-03