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Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication

Primary Purpose

Obesity, Childhood

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Novel risk communication
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity, Childhood focused on measuring risk communication

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • must be a parent of a 5-12 year old child
  • child must be a patient at University of Washington Medical Center
  • child must have BMI at or above 95th percentile for age and sex
  • parent must have home or mobile internet access

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Novel risk communication

    Usual Care

    Arm Description

    Intervention parents will receive a novel risk communication message via a tablet app. Parents will also receive height, weight, and BMI percentile information typically provided by a provider during well-child visits as usual.

    Parents will receive height, weight, and BMI percentile information typically provided by a provider during well-child visits as usual.

    Outcomes

    Primary Outcome Measures

    Frequency of logging meals in food diary
    Frequency of diet monitoring
    Quality of food diary
    Quality of diet monitoring (i.e. recording 5 or more different foods per day)

    Secondary Outcome Measures

    Weight class perception (questionnaire)
    Does parent perceive child to be Underweight/About the right weight/Overweight/Obese
    Anxiety (Perceived Stress Scale)
    Perceived Stress Scale
    Concern about child health (CAHPS)
    In the last 6 months, did you have any questions or concerns about your child's health or health care?

    Full Information

    First Posted
    March 1, 2017
    Last Updated
    March 3, 2017
    Sponsor
    Seattle Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03074929
    Brief Title
    Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication
    Official Title
    Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2017 (Anticipated)
    Primary Completion Date
    September 1, 2020 (Anticipated)
    Study Completion Date
    September 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seattle Children's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    One-third of American children are overweight or obese, leading to an increased risk for cardiovascular disease (CVD), early mortality, and other risks throughout their lifespan relative to normal weight children. In our pilot work, we found that 67-83% of parents underestimate a child's long-term risk of developing cardiovascular disease in adulthood and that parents thought their own child's risks were 13-15% lower than those of a typical child in their community, even controlling for family health and demographic characteristics. Parents were 40 times less likely to predict that their child, rather than a typical child in their community, would be overweight or obese in adulthood. These findings suggest that parents suffer from optimism bias, the tendency to overestimate one's chances of experiencing unlikely positive events. Belief that a child is at increased risk for adverse health outcomes in adulthood could be an important motivator for a family to initiate behavior changes and vice versa. The overall goal of this research is to develop provider-based risk communication approaches to motivate parents of obese children to engage in behavior change to protect their children from CVD and other obesity-related co-morbidities later in life. Specifically, the investigators will: Develop risk communication methods that providers can use to better convey accurate information about a child's health behaviors, obesity status, and future health risks to parents. Using an online experiment, we will evaluate the impact of new risk communication methods on parental engagement in behavior change. Pilot test the feasibility, acceptability, and impact of new risk communication approaches in pediatric primary care clinics. This work will give pediatricians novel tools to effectively discuss the long-term consequences of childhood obesity with parents. The findings from this work will inform an interventional trial that will assess the impact of improved risk communication techniques on child behavior change and health outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Childhood
    Keywords
    risk communication

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Novel risk communication
    Arm Type
    Experimental
    Arm Description
    Intervention parents will receive a novel risk communication message via a tablet app. Parents will also receive height, weight, and BMI percentile information typically provided by a provider during well-child visits as usual.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Parents will receive height, weight, and BMI percentile information typically provided by a provider during well-child visits as usual.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Novel risk communication
    Intervention Description
    The investigators will develop novel risk communication messages to communicate the risks of childhood obesity to parents of children with obesity. The investigators will consider several novel approaches around message content and framing, but primarily, we propose using microsimulation models to forecast a child's long-term health risks, based on his age, race, gender, BMI, and family history of CVD.
    Primary Outcome Measure Information:
    Title
    Frequency of logging meals in food diary
    Description
    Frequency of diet monitoring
    Time Frame
    7 days
    Title
    Quality of food diary
    Description
    Quality of diet monitoring (i.e. recording 5 or more different foods per day)
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Weight class perception (questionnaire)
    Description
    Does parent perceive child to be Underweight/About the right weight/Overweight/Obese
    Time Frame
    7 days
    Title
    Anxiety (Perceived Stress Scale)
    Description
    Perceived Stress Scale
    Time Frame
    7 days
    Title
    Concern about child health (CAHPS)
    Description
    In the last 6 months, did you have any questions or concerns about your child's health or health care?
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: must be a parent of a 5-12 year old child child must be a patient at University of Washington Medical Center child must have BMI at or above 95th percentile for age and sex parent must have home or mobile internet access Exclusion Criteria: None
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Davene R Wright, PhD
    Phone
    206-884-8241
    Email
    davene.wright@seattlechildrens.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication

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