AzTrials
AzTrials

ObesityPhase 2SHINE-GarfieldNCT00462267

Examining the Feasibility of Collaborative Care Treatment for Overweight Adolescents

A Phase 2 study testing Enriched lifestyle intervention in people with Obesity and Overweight, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 to 15 years, women onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Overweight
What is being tested?
Enriched lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
215 participants
Where
1 siteUnited States
Study dates
Jan 2005to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 15 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kaiser Permanente Center for Health Research

    Portland, Oregon, 97227

Other trials in United States

About this study

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.

Read the detailed description

Overweight / obesity among youth has recently been declared a "public health crisis" in the United States and other Western countries due to its alarming increase in prevalence (Flegal, 1999; Kohn \& Booth, 2003; Lobstein et al., 2004; Sokol, 2000). Over the past decade, overweight in youth (Body mass index [BMI] > 95th percentile) has increased 4% for school-age children, 6 - 11 years old. Adolescents, 12 - 19 years of age are even more overweight (5%) (Ogden et al., 2002). Further, American adolescents had the highest prevalence of overweight among 15 western countries included in a cross-sectional, nationally representative school-based study (Lissau et al., 2004). Such trends are particularly troubling given the psychosocial and physical health risks associated with being overweight in childhood (Must \& Strauss, 1999). Overweight among youth appears to confer longer-term health risks even among later normative weight adults (Must et al., 1992). Further, both longer-term health risks and the probability of adult obesity is greater for overweight adolescents than for those developing weight problems earlier in childhood (Must et al., 1992; Whitaker et al., 1997). Collectively, these factors suggest adolescent weight control is an important public health priority.

Clinic-based weight control treatments for youth have demonstrated some success, however, most empirically-supported interventions have been designed for younger school-age children and their families (see Epstein et al., 1998 for a review). Even though a large volume of research explores adult-weight control (see NIH-NHLBI, 1998 for a review) and (though more limited) substantial research examines childhood obesity (see Epstein et al., 1998 for a review), obesity treatments for adolescents have not been adequately studied. Furthermore, almost all empirically tested weight control interventions among youth have been based in academic research clinics rather than the primary care medical settings, in which weight problems among these youth are most often identified and, arguably, in which they could be most efficiently treated. Placing adolescent weight-related interventions within primary medical care settings could make such interventions both more cost-effective and easier to disseminate. The purpose of this study is to assess the feasibility, acceptability, relative cost, and efficacy of a collaborative primary care-based behavioral lifestyle intervention (Enriched Intervention - EI) for overweight adolescent females and their families. This multi-component intervention, adapted for gender and developmental stage, will include a combination of assessment, group teen and parent sessions, individual telephone-based coaching contact, and a distinct collaborative care component with follow-up visits to the youth's primary care provider [PCP]. Further, we will compare the EI to a low intensity intervention [LII] (assessment and information about healthy diet and activity, and follow-up visits with the youth's PCP) and a usual care control condition.

We hypothesize that:

  1. Adolescents participating in the Enriched Intervention (EI) will have a greater decrease in BMI percentile scores than adolescents receiving the Low Intensity Intervention (LII) or Usual Care.
  2. Adolescent in EI will have improved healthy lifestyle skills (e.g., more physical activity, less junk food and sodas) compared with those receiving LII or Usual Care.
  3. Adolescents in EI will report higher psychosocial functioning and quality of life outcomes than those receiving LII or Usual Care.
  4. Neither intervention will result in increases in problematic eating or weight-related behaviors or beliefs.
Conditions
Obesity, Overweight
Being tested
Enriched lifestyle intervention
Keywords
Nutrition, Exercise, Body mass index, Lifestyle change, Obesity, Overweight, Adolescents, Teens
Medical subject headings
Obesity, Overweight, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enriched lifestyle interventionBehavioural

    Multi-component lifestyle intervention

Study groups in NCT00462267
Study groupRoleWhat they receive
Usual careNo interventionNot described
Enriched lifestyle interventionExperimentalNot described
Receives: Behavioral: Enriched lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI z-score

    Measured: 2 years

Secondary outcomes (12)
  1. Quality of life (PedsQL 4.0)

    Measured: 2 years

  2. Self esteem (RSE)

    Measured: 2 years

  3. Depression (PHQ-A)

    Measured: 2 years

  4. Unhealthy eating practices (QEWPR-A, TFEQ)

    Measured: 2 years

  5. Weight and shape concerns (WCS)

    Measured: 2 years

  6. Sociocultural attitudes toward appearance (SATAQ)

    Measured: 2 years

  7. Participant satisfaction with the intervention

    Measured: 2 years

  8. Dietary intake

    Measured: 2 years

  9. Personal and family eating patterns

    Measured: 2 years

  10. Physical activity

    Measured: 2 years

  11. Sedentary behaviors

    Measured: 2 years

  12. Personal and family physical activity patterns

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2007 (estimated)
  2. Study startJan 2005
  3. Primary completionDec 2009
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00462267
Sponsor's protocol ID
101-9295
Acronym
SHINE-Garfield
Status last verified
Apr 2015
First submitted
17 Apr 2007
Last updated
6 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enriched lifestyle intervention in people with Obesity and Overweight, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI z-score (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in