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
About this trial
This is an interventional health services research trial for Obesity, Childhood focused on measuring risk communication
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
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
NCT ID
NCT03074929
First Posted
March 1, 2017
Last Updated
March 3, 2017
Sponsor
Seattle Children's Hospital
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
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Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication
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