ChangeGradients for Adolescent Health Behaviors

Recruiting at 1 trial location

Overseen By Alison S Giovanelli, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

200 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that ChangeGradients for Adolescent Health Behaviors is an effective treatment?

The available research does not provide specific data on the effectiveness of ChangeGradients for Adolescent Health Behaviors. Instead, it focuses on other initiatives and quality improvement projects related to childhood obesity and asthma management. These projects highlight improvements in physician communication, management of pediatric obesity, and continuous improvement learning for healthcare providers, but they do not directly address the effectiveness of ChangeGradients. ^{1 2 3 4 5}

What safety data exists for ChangeGradients treatment?

The provided research does not contain specific safety data for the treatment ChangeGradients or its variants. The studies focus on general adverse drug events (ADEs) in various contexts, such as internal medicine, ambulatory care, and pediatric cases, but do not mention ChangeGradients specifically. ^{6 7 8 9 10}

Is ChangeGradients a promising treatment for improving adolescent health behaviors?

Yes, ChangeGradients is a promising treatment because it focuses on helping adolescents form healthier habits during a crucial time in their lives. This approach can lead to long-lasting positive changes in diet and physical activity, which are important for their current and future health. ^{11 12 13 14 15}

What is the purpose of this trial?

As most adolescents visit a healthcare provider once a year, health behavior change interventions linked to clinic-based health information technologies hold significant promise for improving healthcare quality and subsequent behavioral health outcomes for adolescents (Baird, 2014, Harris, 2017). Recognizing the potential to leverage recent advances in machine learning and interactive narrative environments, the investigators are now well positioned to design health behavior change systems that extend the reach of clinicians to realize significant impacts on behavior change for adolescent preventive health. The proposed project centers on the design, development, and evaluation of a clinically-integrated health behavior change system for adolescents. CHANGEGRADIENTS will introduce an innovative reinforcement learning-based feedback loop in which adolescent patients interact with personalized behavior change interactive narratives that are dynamically personalized and realized in a rich narrative-centered virtual environment. CHANGEGRADIENTS will iteratively improve its behavior change models using policy gradient methods for Reinforcement Learning (RL) designed to optimize adolescents' achieved behavior change outcomes. This in turn will enable CHANGEGRADIENTS to generate more effective behavior change narratives, which will then lead to further improved behavior change outcomes. With a focus on risky behaviors and an emphasis on alcohol use, adolescents will interact with CHANGEGRADIENTS to develop an experiential understanding of the dynamics and consequences of their alcohol use decisions. The proposed project holds significant transformative potential for (1) producing theoretical and practical advances in how to realize significant impacts on adolescent health behavior change through novel interactive narrative technologies integrated with policy-based reinforcement learning, (2) devising sample-efficient policy gradient methods for RL that produce personalized behavior change experiences by integrating theoretically based models of health behavior change with data-driven models of interactive narrative generation, and (3) promoting new models for integrating personalized health behavior change technologies into clinical care that extend the effective reach of clinicians.

Research Team

Elizabeth M Ozer, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for English-speaking adolescents aged 15-17 who visit UCSF Pediatric primary care clinics for a regular check-up and report current alcohol use. It's focused on those interested in changing risky behaviors, especially related to alcohol consumption.

Inclusion Criteria

Presenting for a well-visit at UCSF Pediatric primary care clinics (the Mt. Zion Pediatric Primary Care Practices at UCSF and The Adolescent/Young Adult Clinic at UCSF)

I am between 15 and 17 years old.

You need to tell us if you currently drink alcohol.

Exclusion Criteria

Non-English speakers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Adolescents interact with the CHANGEGRADIENTS system to develop an experiential understanding of alcohol use decisions and behavior change

4 weeks

1 visit (in-person) for baseline, followed by virtual interactions

Follow-up

Participants are monitored for changes in self-efficacy and alcohol use behavior

4 weeks

1 visit (in-person) for assessment

Quality of Care Assessment

Assessment of the quality of care delivered to adolescents using the Adolescent Report of the Visit (AROV)

Immediately following baseline clinic visit

Treatment Details

Interventions

• ChangeGradients

Trial Overview CHANGEGRADIENTS is being tested; it's an innovative system that uses interactive narratives and machine learning to help teens understand the consequences of their choices regarding alcohol use. The goal is to improve health behaviors through personalized virtual stories.

Participant Groups

Group I: ChangeGradients Experimental Treatment 1 Intervention

100 adolescents will be enrolled in the CHANGEGRADIENTS intervention.

Group II: Comparison, non-intervention condition Active Control 1 Intervention

100 participants will not participate in the ChangeGradients intervention, and will continue to have treatment as usual at the clinic.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

North Carolina State University

Collaborator

Trials

38

Recruited

50,000+

Findings from Research

A practice improvement initiative in a family medicine residency clinic successfully enhanced physician communication skills regarding childhood obesity, leading to better management of unhealthy pediatric weight.

The initiative resulted in increased rates of weight management counseling by physicians, indicating a positive impact on addressing childhood obesity in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting conversations between physicians and families about childhood obesity: evaluation of physician communication training within a clinical practice improvement initiative. Shue, CK., Whitt, JK., Daniel, L., et al.[2017]

Physicians need to actively participate in designing and improving health care delivery models, using scientific principles to enhance patient outcomes based on evidence.

Graduate medical education can effectively prepare future physicians to engage in continuous improvement by equipping them with skills to assess health needs, measure outcomes, and collaborate in interdisciplinary teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous improvement learning for residents. Headrick, LA., Richardson, A., Priebe, GP.[2000]

A quality improvement project in a rural pediatric primary care office successfully integrated a toolkit for managing pediatric obesity, which included educational resources and management algorithms, into their electronic medical records.

After 8 weeks of implementation, providers reported improved patient interactions and increased effectiveness in evaluating families' readiness to change, indicating that the toolkit is a valuable resource for addressing pediatric obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved management of pediatric obesity in the primary care setting through implementation of the healthy care for healthy kids obesity toolkit. Thomas, LN., Donadio, A., Carnevale, T., et al.[2022]

The Childhood Healthy Behaviors Intervention (CHBI) significantly improved pediatric primary care providers' recognition of childhood overweight and obesity, with appropriate diagnostic coding increasing from 52% to 68% after the intervention.

The intervention also enhanced providers' assessment and counseling practices regarding healthy habits, with health habit assessments rising from 0% to 76% and goal setting for healthy behaviors increasing from 12% to 70%, demonstrating its efficacy in addressing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying Provider Practice To Improve Assessment of Unhealthy Weight and Lifestyle in Young Children: Translating Evidence in a Quality Improvement Initiative for At-Risk Children. Camp, NL., Robert, RC., Nash, JE., et al.[2018]

A team of healthcare professionals focused on improving asthma management by evaluating current practices and developing guidelines, which involved surveying primary care physicians and specialists to understand their methods.

The pilot of a patient outcomes survey tool showed it was effective for tracking asthma patient outcomes, leading to the creation of educational materials for both patients and providers to enhance asthma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical practice improvement: management of the patient with chronic asthma. Weiss, M.[2019]

In a study analyzing 1,567,659 hospital discharges in Spain from 2005-2007, 96,607 adverse drug events (ADEs) were identified, representing 5.55% of all discharges, with a significant portion (82.86%) deemed not preventable.

The study found that adverse drug reactions (ADRs) were more common in women and led to longer hospital stays, highlighting the importance of monitoring and reporting ADEs for improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse drug events in patients hospitalized in internal medicine]. Zapatero Gaviria, A., Barba, R., Ruiz Giardin, JM., et al.[2013]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

Out of 279 systematic reviews analyzed, only 70.61% considered the impact of interventions/controls on adverse events, while other important effect modifiers like treatment duration (21.15%) and dosage (24.73%) were rarely investigated.

The study highlights a significant gap in current systematic reviews regarding the assessment of effect modifiers on harmful effects, suggesting that methodological guidelines should include these factors to improve the evaluation of safety in healthcare interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. Zhou, X., Yang, X., Cai, F., et al.[2023]

In 2006, out of over 7.5 million pediatric hospital discharges, there were 84,510 adverse drug events (ADEs), representing 0.9% of total discharges, with the majority being adverse effects rather than accidental poisonings.

The study highlighted that the most common ADEs were associated with antineoplastic and immunosuppressive drugs, and the overall burden of pediatric ADEs was significant, leading to an estimated 104,230 excess hospital days and direct costs of $252.9 million.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The national burden of E-code-identified adverse drug events among hospitalized children using a national discharge database. Tundia, NL., Heaton, PC., Kelton, CM.[2022]

The RADARx software program effectively identified 34 actual adverse drug events (ADEs) and 48 potential ADEs, significantly outperforming traditional methods that only detected 23 ADEs during the evaluation period.

Despite generating 8-20 alerts daily, which required 10 to 30 minutes of pharmacist review, only 11% of RADARx alerts were confirmed as true positives, highlighting the need for efficient screening tools to manage ADEs in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RADARx: Recognizing, Assessing, and Documenting Adverse Rx events. Brown, S., Black, K., Mrochek, S., et al.[2019]

A pilot study involving 336 students showed that a school-based health intervention effectively reduced extreme alcohol use, smoking, sedentary time, and bullying behaviors over a 3-year period.

The intervention had different impacts on boys and girls, with significant changes in behaviors like alcohol use and bullying victimization observed in girls, while boys showed changes in sedentary behaviors, highlighting the need for tailored approaches in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a multibehavioral health-promoting school pilot intervention in a Dutch secondary school. Busch, V., De Leeuw, RJ., Schrijvers, AJ.[2018]

The EACH-B intervention, designed for secondary school students, aims to improve dietary quality and physical activity through a combination of teacher training, in-school lessons, and a personalized digital platform, with a target recruitment of about 2300 students from 50 schools.

This cluster randomised controlled trial will assess the effectiveness of the EACH-B intervention over two academic years, highlighting the importance of engaging adolescents in healthy behavior changes for their long-term health and that of future generations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity. Strömmer, S., Barrett, M., Woods-Townsend, K., et al.[2021]

The study identified key questionnaires for assessing adolescent self-esteem, self-perception, physical exercise, and lifestyle, highlighting the Rosenberg Self-Esteem Scale as the most reliable tool for self-esteem assessment.

The Physical Activity Questionnaire for Adolescents was recognized as the best instrument for evaluating physical activity, while the Health Behavior in School-aged Children questionnaire effectively assesses lifestyle habits across different countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Questionnaires Assessing Adolescents' Self-Concept, Self-Perception, Physical Activity and Lifestyle: A Systematic Review. Palenzuela-Luis, N., Duarte-Clíments, G., Gómez-Salgado, J., et al.[2022]

The pilot study involving 71 participants demonstrated that group obesity management visits in school-based health centers were feasible and well-received, particularly among Latinx and African American youth.

Quantitative results indicated significant improvements, including reduced soda consumption, increased exercise days, and enhanced social support, while qualitative feedback highlighted the value of cooking activities and family involvement in promoting healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact on Healthy Behaviors of Group Obesity Management Visits in Middle School Health Centers. Schapiro, NA., Green, EK., Kaller, S., et al.[2021]

The ACTION program, a school-based health center weight management initiative, showed feasibility and effectiveness in improving BMI percentile and waist circumference among overweight/obese adolescents compared to standard care.

Out of 60 enrolled participants, 51 completed the study, and those in the ACTION group experienced significant improvements in body measurements, indicating that structured interventions can positively impact adolescent health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based health center intervention improves body mass index in overweight and obese adolescents. Kong, AS., Sussman, AL., Yahne, C., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Promoting conversations between physicians and families about childhood obesity: evaluation of physician communication training within a clinical practice improvement initiative. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Continuous improvement learning for residents. [2000]

3. United States pubmed.ncbi.nlm.nih.gov

Improved management of pediatric obesity in the primary care setting through implementation of the healthy care for healthy kids obesity toolkit. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Modifying Provider Practice To Improve Assessment of Unhealthy Weight and Lifestyle in Young Children: Translating Evidence in a Quality Improvement Initiative for At-Risk Children. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Clinical practice improvement: management of the patient with chronic asthma. [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

[Adverse drug events in patients hospitalized in internal medicine]. [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Effect of important modifiers on harmful effects in evidence synthesis practice of adverse events were insufficiently investigated: an empirical investigation. [2023]

9. England pubmed.ncbi.nlm.nih.gov

The national burden of E-code-identified adverse drug events among hospitalized children using a national discharge database. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

RADARx: Recognizing, Assessing, and Documenting Adverse Rx events. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Results of a multibehavioral health-promoting school pilot intervention in a Dutch secondary school. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Questionnaires Assessing Adolescents' Self-Concept, Self-Perception, Physical Activity and Lifestyle: A Systematic Review. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Impact on Healthy Behaviors of Group Obesity Management Visits in Middle School Health Centers. [2021]

15. United States pubmed.ncbi.nlm.nih.gov

School-based health center intervention improves body mass index in overweight and obese adolescents. [2022]