- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: Usual Care
Parents will receive height, weight, and BMI percentile information typically provided by a provider during well-child visits as usual.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of logging meals in food diary
Tidsramme: 7 days
|
Frequency of diet monitoring
|
7 days
|
|
Quality of food diary
Tidsramme: 7 days
|
Quality of diet monitoring (i.e.
recording 5 or more different foods per day)
|
7 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight class perception (questionnaire)
Tidsramme: 7 days
|
Does parent perceive child to be Underweight/About the right weight/Overweight/Obese
|
7 days
|
|
Anxiety (Perceived Stress Scale)
Tidsramme: 7 days
|
Perceived Stress Scale
|
7 days
|
|
Concern about child health (CAHPS)
Tidsramme: 7 days
|
In the last 6 months, did you have any questions or concerns about your child's health or health care?
|
7 days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15895
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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