Managing Patient Expectations in Pediatric Weight Management
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Expectations
Patient Expectations
Sponsored by

About this trial
This is an interventional health services research trial for Obesity focused on measuring Obesity, Children, Adolescents, Attrition
Eligibility Criteria
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
Sites / Locations
- Children's Hospital, Colorado
- Connecticut Children's Medical Center
- Children's Hospital of Illinois
- Kosair Children's Hospital
- Mt. Washington Pediatric Hospital
- Boston Children's Hospital
- C.S. Mott Children's Hospital
- Helen DeVos Children's Hospital
- Children's Mercy Hospitals & Clinics
- Children's Hospital and Medical Center, Omaha
- Nationwide Children's Hospital
- Doernbecher Children's Hospital OHSU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient Expectations
Arm Description
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.
Outcomes
Primary Outcome Measures
Attrition at 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
Congruence of learning needs and achieved outcomes
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.
Full Information
NCT ID
NCT01753063
First Posted
December 17, 2012
Last Updated
December 16, 2013
Sponsor
Boston Children's Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT01753063
Brief Title
Managing Patient Expectations in Pediatric Weight Management
Official Title
Managing Expectations in Pediatric Weight Management: A Pilot Study in Focus on a Fitter Future III Hospitals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Children's Hospital
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
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Children, Adolescents, Attrition
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Expectations
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Expectations
Intervention Description
Baseline Expectations survey (parent/guardian and adolescents 12 and older)
Intervention Type
Behavioral
Intervention Name(s)
Patient Expectations
Intervention Description
3 month follow up survey (parent/guardian and adolescents 12 and older)
Primary Outcome Measure Information:
Title
Attrition at 3 months
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Congruence of learning needs and achieved outcomes
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Matched expectations between parent and child expectations at baseline
Description
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.
Time Frame
Baseline
Title
Child BMI Z-score
Description
Change in BMI z-score between baseline and 3 month follow-up
Time Frame
Baseline, 3 months
Title
Provider Satisfaction
Description
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.
Time Frame
3 months
Title
Participation Rate
Description
Proportion of patients who enrolled among those invited to participate.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erinn Rhodes, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarah Hampl, MD
Organizational Affiliation
Children's Mercy Hospitals & Clinics
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital, Colorado
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
Children's Hospital of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Mt. Washington Pediatric Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Helen DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
Children's Mercy Hospitals & Clinics
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Children's Hospital and Medical Center, Omaha
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Doernbecher Children's Hospital OHSU
City
Portland
State/Province
Oregon
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23539682
Citation
Hampl S, Demeule M, Eneli I, Frank M, Hawkins MJ, Kirk S, Morris P, Sallinen BJ, Santos M, Ward WL, Rhodes E. Parent perspectives on attrition from tertiary care pediatric weight management programs. Clin Pediatr (Phila). 2013 Jun;52(6):513-9. doi: 10.1177/0009922813482515. Epub 2013 Mar 28. Erratum In: Clin Pediatr (Phila). 2014 Mar;53(3):NP1.
Results Reference
background
PubMed Identifier
24028563
Citation
Sallinen Gaffka BJ, Frank M, Hampl S, Santos M, Rhodes ET. Parents and pediatric weight management attrition: experiences and recommendations. Child Obes. 2013 Oct;9(5):409-17. doi: 10.1089/chi.2013.0069. Epub 2013 Sep 12.
Results Reference
background
PubMed Identifier
28092464
Citation
Rhodes ET, Boles RE, Chin K, Christison A, Testa EG, Guion K, Hawkins MJ, Petty CR, Sallinen Gaffka B, Santos M, Shaffer L, Tucker J, Hampl SE. Expectations for Treatment in Pediatric Weight Management and Relationship to Attrition. Child Obes. 2017 Apr;13(2):120-127. doi: 10.1089/chi.2016.0215. Epub 2017 Jan 16.
Results Reference
derived
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Managing Patient Expectations in Pediatric Weight Management
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