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Managing Patient Expectations in Pediatric Weight Management

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.
ClinicalTrials.gov Identifier: NCT01753063
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : December 17, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
As part of Children's Hospital Association's Focus on a Fitter Future III Obesity Task Force, this project will target patient and family expectations across the domains of nutrition, physical activity and behavior change/family support as a means of patient engagement and retention in pediatric weight management. This will be a prospective, non-randomized, uncontrolled, single-arm trial for children between 2 and 18 years of age and a parent/guardian, who are starting a pediatric weight management program/clinic in one of the participating centers. The parent/guardian and child if 12 years of age or older receive a survey at the first visit, which asks about their expectations and goals for the visit. This information will then be used as part of clinical care to tailor treatment. After 3 months, the parent/guardian and adolescent, if applicable, will receive a follow up survey asking about their progress in these areas.

Condition or disease Intervention/treatment
Obesity Behavioral: Patient Expectations

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Managing Expectations in Pediatric Weight Management: A Pilot Study in Focus on a Fitter Future III Hospitals
Study Start Date : January 2013
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Patient Expectations
At the family's initial visit to the pediatric weight management program/clinic each parent/guardian and adolescent (if age 12 yrs. or older) will complete the survey tool. At 3 months, families will be asked to complete a follow up survey. This will be fielded at a visit for those returning to clinic or by phone/mail for those not returning.
Behavioral: Patient Expectations
Baseline Expectations survey (parent/guardian and adolescents 12 and older)
Behavioral: Patient Expectations
3 month follow up survey (parent/guardian and adolescents 12 and older)

Outcome Measures

Primary Outcome Measures :
  1. Attrition at 3 months [ Time Frame: 3 months ]
    Defined for treatment clinics (i.e., no set end point) as attending an initial appointment but no further appointments in a 3 month period. For treatment programs (i.e., set end point), attrition is defined as attending <25% of visits in a 3 month period

Secondary Outcome Measures :
  1. Congruence of learning needs and achieved outcomes [ Time Frame: 3 months ]
    Defined as a match between the identified most important treatment expectation in each of the domains at baseline and the most helpful treatment domains at 3 months. Congruent = at least 4 out 6 possible matches.

Other Outcome Measures:
  1. Matched expectations between parent and child expectations at baseline [ Time Frame: Baseline ]
    match between the identified most important treatment expectation in each of the domains at baseline for the parent and adolescent (age 12+). Matched= at least 4 out 6 possible matches.

  2. Child BMI Z-score [ Time Frame: Baseline, 3 months ]
    Change in BMI z-score between baseline and 3 month follow-up

  3. Provider Satisfaction [ Time Frame: 3 months ]
    Providers will complete a brief survey at the end of the recruitment phase to solicit general feedback and to assess the tool's utility and impact on clinical flow.

  4. Participation Rate [ Time Frame: Baseline ]
    Proportion of patients who enrolled among those invited to participate.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject conversant in English or Spanish
  • Parent/guardian conversant in English or Spanish
  • Patient aged 2-18 years

Exclusion Criteria (For Adolescent):

• Parent-reported cognitive issues preventing completion of the form, such as in-school aide>50% of the school day; special education classes >50% of school day

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01753063

United States, Colorado
Children's Hospital, Colorado
Denver, Colorado, United States
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States
United States, Illinois
Children's Hospital of Illinois
Peoria, Illinois, United States, 61637
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States
United States, Maryland
Mt. Washington Pediatric Hospital
Baltimore, Maryland, United States, 21209
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
C.S. Mott Children's Hospital
Ann Arbor, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
United States, Missouri
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States
United States, Nebraska
Children's Hospital and Medical Center, Omaha
Omaha, Nebraska, United States
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States
United States, Oregon
Doernbecher Children's Hospital OHSU
Portland, Oregon, United States
Sponsors and Collaborators
Boston Children’s Hospital
University of Nebraska
Nationwide Children's Hospital
Connecticut Children's Medical Center
Mt. Washington Pediatric Hospital
C.S. Mott Children's Hospital
Children's Hospital Colorado
Children's Hospital of Illinois
Helen DeVos Children's Hospital
OHSU Doernbecher Children's Hospital
Norton Healthcare
Study Chair: Erinn Rhodes, MD, MPH Boston Children’s Hospital
Study Chair: Sarah Hampl, MD Children's Mercy Hospitals & Clinics