Managing Patient Expectations in Pediatric Weight Management
This study is enrolling participants by invitation only.
Sponsor:
Children's Hospital Boston
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
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Purpose
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 | Intervention |
|---|---|
|
Obesity |
Behavioral: Patient Expectations |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Boston:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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.
Other Outcome Measures:
- 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.
| Estimated Enrollment: | 770 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753063
Locations
| 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
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
Investigators
| Study Chair: | Erinn Rhodes, MD, MPH | Boston Children's Hospital |
| Study Chair: | Sarah Hampl, MD | Children's Mercy Hospitals & Clinics |
More Information
No publications provided
| Responsible Party: | Children's Hospital Boston |
| ClinicalTrials.gov Identifier: | NCT01753063 History of Changes |
| Other Study ID Numbers: | P00006045 |
| Study First Received: | December 17, 2012 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
Obesity Children Adolescents Attrition |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013