- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01753063
Managing Patient Expectations in Pediatric Weight Management
December 16, 2013 updated by: Boston Children's Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
405
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Denver, Colorado, United States
- Children's Hospital, Colorado
-
-
Connecticut
-
Hartford, Connecticut, United States
- Connecticut Children's Medical Center
-
-
Illinois
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Peoria, Illinois, United States, 61637
- Children's Hospital of Illinois
-
-
Kentucky
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Louisville, Kentucky, United States
- Kosair Children's Hospital
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-
Maryland
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Baltimore, Maryland, United States, 21209
- Mt. Washington Pediatric Hospital
-
-
Massachusetts
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Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
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-
Michigan
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Ann Arbor, Michigan, United States
- C.S. Mott Children's Hospital
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Grand Rapids, Michigan, United States
- Helen DeVos Children's Hospital
-
-
Missouri
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Kansas City, Missouri, United States
- CHILDREN'S MERCY HOSPITALS & CLINICS
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-
Nebraska
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Omaha, Nebraska, United States
- Children's Hospital and Medical Center, Omaha
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Ohio
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Columbus, Ohio, United States
- Nationwide Children's Hospital
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-
Oregon
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Portland, Oregon, United States
- Doernbecher Children's Hospital OHSU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Baseline Expectations survey (parent/guardian and adolescents 12 and older)
3 month follow up survey (parent/guardian and adolescents 12 and older)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Child BMI Z-score
Time Frame: Baseline, 3 months
|
Change in BMI z-score between baseline and 3 month follow-up
|
Baseline, 3 months
|
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.
|
3 months
|
Participation Rate
Time Frame: Baseline
|
Proportion of patients who enrolled among those invited to participate.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Erinn Rhodes, MD, MPH, Boston Children's Hospital
- Study Chair: Sarah Hampl, MD, CHILDREN'S MERCY HOSPITALS & CLINICS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
December 17, 2012
First Submitted That Met QC Criteria
December 17, 2012
First Posted (Estimate)
December 20, 2012
Study Record Updates
Last Update Posted (Estimate)
December 17, 2013
Last Update Submitted That Met QC Criteria
December 16, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00006045
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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