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ObesityNCT01753063

Managing Patient Expectations in Pediatric Weight Management

A study testing Patient Expectations in people with Obesity, run by Boston Children's Hospital at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 18 years
Conditions the study is for
Obesity
What is being tested?
Patient Expectations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
405 participants
Where
12 sitesUnited States
Study dates
Jan 2013to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • C.S. Mott Children's Hospital

    Ann Arbor, Michigan

  • Mt. Washington Pediatric Hospital

    Baltimore, Maryland, 21209

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Nationwide Children's Hospital

    Columbus, Ohio

  • Children's Hospital, Colorado

    Denver, Colorado

  • Helen DeVos Children's Hospital

    Grand Rapids, Michigan

  • Connecticut Children's Medical Center

    Hartford, Connecticut

  • Children's Mercy Hospitals & Clinics

    Kansas City, Missouri

  • Kosair Children's Hospital

    Louisville, Kentucky

  • Children's Hospital and Medical Center, Omaha

    Omaha, Nebraska

  • Children's Hospital of Illinois

    Peoria, Illinois, 61637

  • Doernbecher Children's Hospital OHSU

    Portland, Oregon

Other trials in United States

About this study

Official title: 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.

Conditions
Obesity
Being tested
Patient Expectations
Keywords
Obesity, Children, Adolescents, Attrition
Medical subject headings
Obesity, Tooth Wear

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient ExpectationsBehavioural

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

  • Patient ExpectationsBehavioural

    3 month follow up survey (parent/guardian and adolescents 12 and older)

Study groups in NCT01753063
Study groupRoleWhat they receive
Patient ExpectationsExperimentalAt 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.
Receives: Behavioral: Patient Expectations

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 months

Secondary outcomes (1)

  1. Congruence of learning needs and achieved outcomes

    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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01753063
Sponsor's protocol ID
P00006045
Status last verified
Dec 2013
First submitted
17 Dec 2012
Last updated
17 Dec 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23539682

  • 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.

    PubMed 24028563

  • 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.

    PubMed 28092464

Questions about this trial

What is this clinical trial studying?

A study testing Patient Expectations in people with Obesity, run by Boston Children's Hospital at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Attrition at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01753063, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.

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