- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03074929
Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Davene R Wright, PhD
- Phone Number: 206-884-8241
- Email: davene.wright@seattlechildrens.org
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novel risk communication
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.
|
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.
|
No Intervention: Usual Care
Parents will receive height, weight, and BMI percentile information typically provided by a provider during well-child visits as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of logging meals in food diary
Time Frame: 7 days
|
Frequency of diet monitoring
|
7 days
|
Quality of food diary
Time Frame: 7 days
|
Quality of diet monitoring (i.e.
recording 5 or more different foods per day)
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight class perception (questionnaire)
Time Frame: 7 days
|
Does parent perceive child to be Underweight/About the right weight/Overweight/Obese
|
7 days
|
Anxiety (Perceived Stress Scale)
Time Frame: 7 days
|
Perceived Stress Scale
|
7 days
|
Concern about child health (CAHPS)
Time Frame: 7 days
|
In the last 6 months, did you have any questions or concerns about your child's health or health care?
|
7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15895
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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