NCT01753063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

December 17, 2012

Last Update Submit

December 16, 2013

Conditions

Keywords

ObesityChildrenAdolescentsAttrition

Outcome Measures

Primary Outcomes (1)

  • Attrition at 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 Outcomes (1)

  • Congruence of learning needs and achieved outcomes

    3 months

Other Outcomes (4)

  • Matched expectations between parent and child expectations at baseline

    Baseline

  • Child BMI Z-score

    Baseline, 3 months

  • Provider Satisfaction

    3 months

  • +1 more other outcomes

Study Arms (1)

Patient Expectations

EXPERIMENTAL

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

Interventions

Baseline Expectations survey (parent/guardian and adolescents 12 and older)

Patient Expectations

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subject conversant in English or Spanish
  • Parent/guardian conversant in English or Spanish
  • Patient aged 2-18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Children's Hospital, Colorado

Denver, Colorado, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Location

Children's Hospital of Illinois

Peoria, Illinois, 61637, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, United States

Location

Mt. Washington Pediatric Hospital

Baltimore, Maryland, 21209, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

C.S. Mott Children's Hospital

Ann Arbor, Michigan, United States

Location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Location

Children's Mercy Hospitals & Clinics

Kansas City, Missouri, United States

Location

Children's Hospital and Medical Center, Omaha

Omaha, Nebraska, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, United States

Location

Doernbecher Children's Hospital OHSU

Portland, Oregon, United States

Location

Related Publications (3)

  • 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.

    PMID: 23539682BACKGROUND
  • 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.

    PMID: 24028563BACKGROUND
  • 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.

MeSH Terms

Conditions

ObesityTooth Wear

Interventions

Treatment Expectations

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Treatment OutcomePrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Erinn Rhodes, MD, MPH

    Boston Children's Hospital

    STUDY CHAIR
  • Sarah Hampl, MD

    Children's Mercy Hospitals & Clinics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 20, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations