NCT03074929

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:

  1. 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. 2.Using an online experiment, we will evaluate the impact of new risk communication methods on parental engagement in behavior change.
  3. 3.Pilot test the feasibility, acceptability, and impact of new risk communication approaches in pediatric primary care clinics.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

March 1, 2017

Last Update Submit

March 3, 2017

Conditions

Keywords

risk communication

Outcome Measures

Primary Outcomes (2)

  • Frequency of logging meals in food diary

    Frequency of diet monitoring

    7 days

  • Quality of food diary

    Quality of diet monitoring (i.e. recording 5 or more different foods per day)

    7 days

Secondary Outcomes (3)

  • Weight class perception (questionnaire)

    7 days

  • Anxiety (Perceived Stress Scale)

    7 days

  • Concern about child health (CAHPS)

    7 days

Study Arms (2)

Novel risk communication

EXPERIMENTAL

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.

Behavioral: Novel risk communication

Usual Care

NO INTERVENTION

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

Interventions

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.

Novel risk communication

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 1, 2017

First Posted

March 9, 2017

Study Start

November 1, 2017

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share