Obesity, ChildhoodNCT03074929
Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication
A study testing Novel risk communication in people with Obesity, Childhood, run by Seattle Children's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Novel risk communication
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
No sites are listed yet.
About this study
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:
Read more
- 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.
- Conditions
- Obesity, Childhood
- Being tested
- Novel risk communication
- Keywords
- risk communication
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel risk communicationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of logging meals in food diary
Frequency of diet monitoring
Measured: 7 days
Quality of food diary
Quality of diet monitoring (i.e. recording 5 or more different foods per day)
Measured: 7 days
Secondary outcomes (3)
Weight class perception (questionnaire)
Does parent perceive child to be Underweight/About the right weight/Overweight/Obese
Measured: 7 days
Anxiety (Perceived Stress Scale)
Perceived Stress Scale
Measured: 7 days
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?
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davene Wright, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074929
- Sponsor's protocol ID
- 15895
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Childhood Obesity-Related Behavior Change Through Better Risk Communication
- ClinicalTrials.gov ID
- NCT03074929
- Acronym / sponsor ID
- 15895
- Conditions
- Obesity, Childhood
- Keywords
- risk communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novel risk communication | Experimental | Behavioral: Novel risk communicationIntervention 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. |
| Usual Care | No intervention | –Parents will receive height, weight, and BMI percentile information typically provided by a provider during well-child visits as usual. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel risk communicationThe 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. | Behavioural | Novel risk communication |
Primary outcome
Frequency of logging meals in food diary
Time frame: 7 days
Frequency of diet monitoring
Quality of food diary
Time frame: 7 days
Quality of diet monitoring (i.e. recording 5 or more different foods per day)
3 secondary outcomes
Weight class perception (questionnaire)
Time frame: 7 days
Anxiety (Perceived Stress Scale)
Time frame: 7 days
Concern about child health (CAHPS)
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Novel risk communication in people with Obesity, Childhood, run by Seattle Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Davene R Wright, PhD (206-884-8241, davene.wright@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of logging meals in food diary (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.