Check Yourself Study

Health Risk Behaviors Clinical Trial

Official title:

Promoting Adolescent Health Through Personalized Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02360410
• Other study ID #: 6 R40MC26817-01-01
• Status: Completed
• Phase: N/A
• First received: February 5, 2015
• Last updated: April 17, 2018
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2018
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study is a randomized controlled trial that compares the effectiveness of an electronic personalized health screening app incorporating motivational feedback (i.e., "Check Yourself") to usual care. The purpose of this study is to determine whether Check Yourself is more effective than usual care in reducing health risk behaviors and improving quality of care among adolescents receiving primary health care services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English.

Exclusion Criteria:

• Individuals will be excluded from the study if:

• they do not meet age requirements,

• do not have an appointment at a participating clinic,

• lack the means to complete follow-up interviews (i.e., has neither telephone not internet access),

• have a sibling who has/is being enrolled in the study and/or

• are not able to read or comprehend English.

Related Conditions & MeSH terms

• Health Care Services Quality of Care
• Health Risk Behaviors

Intervention

Behavioral:
• Check Yourself App with Feedback

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Laura Richardson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adolescent Perceived Support from their Primary Care Provider	The total score on the Health Care Climate Questionnaire (HCCQ),) will be used to assess adolescent self-report of perceived autonomy support from their primary care provider.	1 day
Other	Adolescent Health Self-Efficacy	The total score on the Health Self Efficacy Scale will be used to assess adolescent self-report of perceived confidence in ability to execute health behaviors.	1 day
Primary	Number of Health risk behaviors	Total count health-risk behaviors at 3-month follow-up (Score range= 0-13) adjusted by total number of baseline risk behaviors (with risk cut-off): =2 sugar-sweetened beverages consumed/day; =3 servings fruits/vegetables consumed/day; =3 days with 60+ minutes exercise during typical week; =3 hours of screen time during typical school day; =7 hours of sleep during typical night; not "always" using seatbelt; not "always" using helmet when bicycling; having driven under the influence of substances; days of alcohol consumption in last 30 days (risk based on age: =1 day/30 days (ages 13-15), =2 days/30 days (ages 16-17), or =3 days/30 days (age 18)) and/or number of drinks/drinking episode (risk based on age and sex: =3 (Girls 13-17; Boys 13), =4 (Girls 18; Boys 14-15), or =5 (Boys 16-18)); any tobacco use; any marijuana/other drugs use; not using birth control during last sexual intercourse and/or not "always" using a condom; and =10 score on PHQ-9.	3 months
Primary	Number of risk behaviors counseled on during primary care appointment	Number of adolescent-reported high risk health risk behaviors discussed with the healthcare provider during the primary care visit (Score range: 0-13) adjusted for the total number of health risk behaviors reported at baseline. Receipt of counseling/discussion assessed using an adapted version of the Adolescent Report of the Visit (AROV). The AROV includes counseling on the following behaviors: 1) sweetened beverage consumption; 2) fruit/vegetable consumption; 3) physical activity amount; 4) screen time (i.e., watching TV, playing video games, surfing the web, or texting); 5) sleep duration; 6) seat belt use; 7) helmet use while bicycling; 8) drinking/using drugs while driving; 9) alcohol use; 10) tobacco use; 11) marijuana and/or other drug use; 12) condom and/or birth control use; 13) depression and moods.	1 day
Secondary	Adolescent Satisfaction with Care	Adolescent satisfaction with care will be assessed using the total score on the 8-item Client Satisfaction Questionnaire (CSQ-8) at 1-day follow-up.	1 day
Secondary	Interval Receipt of Care	Dichotomous variable indicating receipt of any follow-up care to address risk behaviors identified at baseline adjusted for baseline number of health risk behaviors.	3 months
Secondary	Motivation for Health Behavior Change	Assessment of adolescent reported motivation to change overall health using a Readiness to Change Ruler.	1 day
Secondary	Specific Health Risk Behavior Change	Reported level for each specific health risk behavior at 3 months adjusting for baseline level of that specific behavior. Specific individual behaviors include: A.) number of: sweetened beverages consumed in a typical day; fruits and vegetables consumed in a typical day; days with >60 minutes of physical activity in an average week; hours of screen time on a typical day; hours of sleep on a typical night; days in which alcohol was consumed in the prior month; alcoholic drinks typically consumed per occasion; any tobacco use in the prior month (yes/no); days using marijuana in the past month; B) Score on the nine item Patient Health Questionnaire (27 point scale); C) Frequency of: seatbelt use in a car (4-point scale); helmet use while bicycling (4-point scale); condom use with sexual intercourse (4-point scale); D) Use of any form of birth control at last sexual intercourse (yes/no); and E) Driving under the influence of a substance (yes/no).	3 months