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Managing Patient Expectations in Pediatric Weight Management

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01753063
First received: December 17, 2012
Last updated: April 17, 2013
Last verified: April 2013
History of Changes

December 17, 2012
April 17, 2013
January 2013
October 2013   (final data collection date for primary outcome measure)
Attrition at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01753063 on ClinicalTrials.gov Archive Site
Congruence of learning needs and achieved outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Same as current
  • Matched expectations between parent and child expectations at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.
  • Child BMI Z-score [ Time Frame: Baseline, 3 months ] [ Designated as safety issue: No ]
    Change in BMI z-score between baseline and 3 month follow-up
  • Provider Satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.
  • Participation Rate [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Proportion of patients who enrolled among those invited to participate.
Same as current
 
Managing Patient Expectations in Pediatric Weight Management
Managing Expectations in Pediatric Weight Management: A Pilot Study in Focus on a Fitter Future III Hospitals

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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Obesity
  • 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)
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.
Interventions:
  • Behavioral: Patient Expectations
  • Behavioral: Patient Expectations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
770
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01753063
P00006045
No
Children's Hospital Boston
Children's Hospital Boston
  • 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
Children's Hospital Boston
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP