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

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
      • Peoria, Illinois, United States, 61637
        • Children's Hospital of Illinois
    • Kentucky
      • Louisville, Kentucky, United States
        • Kosair Children's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21209
        • Mt. Washington Pediatric Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • C.S. Mott Children's Hospital
      • Grand Rapids, Michigan, United States
        • Helen DeVos Children's Hospital
    • Missouri
      • Kansas City, Missouri, United States
        • CHILDREN'S MERCY HOSPITALS & CLINICS
    • Nebraska
      • Omaha, Nebraska, United States
        • Children's Hospital and Medical Center, Omaha
    • Ohio
      • Columbus, Ohio, United States
        • Nationwide Children's Hospital
    • Oregon
      • 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.

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.

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

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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