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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03074929
Other study ID # 15895
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 1, 2017
Last updated March 3, 2017
Start date November 1, 2017
Est. completion date September 1, 2020

Study information

Verified date March 2017
Source Seattle Children's Hospital
Contact Davene R Wright, PhD
Phone 206-884-8241
Email davene.wright@seattlechildrens.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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:

1. 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.

2. Using an online experiment, we will evaluate the impact of new risk communication methods on parental engagement in behavior change.

3. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 1, 2020
Est. primary completion date September 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Novel risk communication
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seattle Children's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of logging meals in food diary Frequency of diet monitoring 7 days
Primary Quality of food diary Quality of diet monitoring (i.e. recording 5 or more different foods per day) 7 days
Secondary Weight class perception (questionnaire) Does parent perceive child to be Underweight/About the right weight/Overweight/Obese 7 days
Secondary Anxiety (Perceived Stress Scale) Perceived Stress Scale 7 days
Secondary 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? 7 days
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