Primary Care Treatment for Overweight Adolescent Females (SHINE) (SHINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068236
Recruitment Status : Completed
First Posted : February 12, 2010
Last Update Posted : March 24, 2010
Information provided by:
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Healthy lifestyle managment Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Primary Care Treatment for Overweight Adolescent Females
Study Start Date : August 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Experimental: Healthy lifestyle intervention
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
Exercise, yoga, food diaries, provider consultation

No Intervention: Usual care
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.

Primary Outcome Measures :
  1. BMI z-score [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: One year ]
  2. Fasting lipid profile [ Time Frame: One year ]
  3. Fasting glucose [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • BMI > 99th percentile,
  • Significant cognitive impairment,
  • Current pregnancy,
  • Congenital heart disease that limits activity,
  • Serious asthma requiring oral prednisone,
  • Taking medications that increase appetite.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068236

Sponsors and Collaborators
Kaiser Permanente
Principal Investigator: Victor J Stevens, PhD Kaiser Permanente

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Victor J. Stevens, PhD /Senior Investigator, Kaiser Permanente Identifier: NCT01068236     History of Changes
Obsolete Identifiers: NCT00451685
Other Study ID Numbers: 5R01HD050931-04 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by Kaiser Permanente:
Teen girls
healthy lifestyle
Weight loss and healthy lifestyle

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms