Clinical trial NCT01753063: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Children
Adolescents
Attrition
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: Nationwide Children's Hospital
name: Connecticut Children's Medical Center
name: Mt. Washington Pediatric Hospital
name: C.S. Mott Children's Hospital
name: Children's Hospital Colorado
name: Children's Hospital of Illinois
name: Helen DeVos Children's Hospital
name: OHSU Doernbecher Children's Hospital
name: Norton Healthcare
First posted: 2012-12-20
Enrollment: 405
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Attrition at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Congruence of learning needs and achieved outcomes
timeFrame: 3 months
Other outcomes:
measure: Matched expectations between parent and child expectations at baseline
timeFrame: Baseline
measure: Child BMI Z-score
timeFrame: Baseline, 3 months
measure: Provider Satisfaction
timeFrame: 3 months
measure: Participation Rate
timeFrame: Baseline
Locations:
city: Denver
country: United States
facility: Children's Hospital, Colorado
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Peoria
country: United States
facility: Children's Hospital of Illinois
state: Illinois
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Baltimore
country: United States
facility: Mt. Washington Pediatric Hospital
state: Maryland
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S. Mott Children's Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital
state: Michigan
city: Kansas City
country: United States
facility: Children's Mercy Hospitals & Clinics
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital and Medical Center, Omaha
state: Nebraska
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Doernbecher Children's Hospital OHSU
state: Oregon
Study officials:
affiliation: Boston Children's Hospital
name: Erinn Rhodes, MD, MPH
role: STUDY_CHAIR
affiliation: Children's Mercy Hospitals & Clinics
name: Sarah Hampl, MD
role: STUDY_CHAIR
References:
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.
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.
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.