Managing Patient Expectations in Pediatric Weight Management

This study has been completed.
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: December 16, 2013
Last verified: December 2013
  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.


Enrollment: 405
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Children's Hospital Boston
Study Chair: Sarah Hampl, MD Children's Mercy Hospitals & Clinics
  More Information

Publications:
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: December 16, 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 August 01, 2014