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Completed

NCT Number: NCT01753063

Managing Patient Expectations in Pediatric Weight Management

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Tooth Wear

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Colorado, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Expectations

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. Child BMI Z-score

    Time frame: Baseline, 3 months

    Change in BMI z-score between baseline and 3 month follow-up

  3. 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.

  4. Participation Rate

    Time frame: Baseline

    Proportion of patients who enrolled among those invited to participate.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • C.S. Mott Children's Hospital
  • Children's Hospital Colorado
  • Children's Hospital of Illinois at Peoria
  • Connecticut Children's Medical Center
  • Helen DeVos Children's Hospital
  • Mt. Washington Pediatric Hospital
  • Nationwide Children's Hospital
  • Norton Healthcare
  • OHSU Doernbecher Children's Hospital
  • University of Nebraska

Registry information

Official study title

Managing Expectations in Pediatric Weight Management: A Pilot Study in Focus on a Fitter Future III Hospitals

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 20, 2012
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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