What side effects are associated with this type of intervention?

Common side effects of behavioral health interventions, such as the Promotores de Salud COVID-19 Health Promotion Intervention with Self-Affirming Implementation Intention (SAII), may include temporary increases in anxiety or stress as individuals work to change their behaviors. Participants might also experience initial resistance or discomfort when adopting new health practices. These side effects are typically mild and short-lived, with the long-term benefits of improved health behaviors and reduced psychological distress outweighing the initial challenges.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at modifying health behaviors and promoting psychological well-being. For smoking cessation, the FDA has approved pharmacotherapies such as nicotine replacement therapy (NRT), bupropion, and varenicline, which help reduce withdrawal symptoms and cravings. Additionally, behavioral interventions like cognitive-behavioral therapy (CBT) and motivational interviewing (MI) are recognized for their effectiveness in promoting health behavior changes and reducing psychological distress. These treatments align with the goals of the Promotores de Salud COVID-19 Health Promotion Intervention with Self-Affirming Implementation Intention (SAII) by supporting individuals in adopting healthier behaviors and improving mental health outcomes.

What other types of research exist?

Promising, novel alternatives to the Promotores de Salud COVID-19 Health Promotion Intervention with Self-Affirming Implementation Intention (SAII) for health behaviors in 2024 include: 1) Digital health interventions such as mobile phone-based apps and web-based platforms that provide real-time monitoring and personalized feedback. 2) Contingency management programs that use incentives to encourage health-promoting behaviors. 3) Mindfulness-based interventions that focus on stress reduction and improving mental health. 4) Social network-based interventions like Tweet2Quit, which leverage social support for behavior change. 5) Acceptance and Commitment Therapy (ACT) delivered via telehealth, which has shown efficacy in promoting health behavior changes.

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Health Education for Improving Health Behaviors

N/A

Recruiting

Led By Dave DeGarmo, PhD

Research Sponsored by University of Oregon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline attitudes towards covid-19 vaccines at 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help Latinx individuals in Oregon feel better about accepting health advice and taking actions like COVID-19 testing. The intervention involves a short exercise where participants think positively about themselves. This approach is expected to make them more open to health messages and reduce barriers like discrimination and mistrust.

Who is the study for?

This trial is for adults over the age of 18 who are attending a Mexican Consulate event that the research team is also attending. It aims to engage with Latinx communities and address COVID-19 health disparities.

What is being tested?

The study tests a behavioral intervention called Self-Affirmation Implementation Intentions (SAII) alongside Promotores de Salud, which is health education provided by community health workers, to see if they improve health behaviors and reduce vaccine hesitancy among Latinx populations.

What are the potential side effects?

Since this trial involves educational interventions rather than medical treatments or drugs, there are no direct physical side effects expected from participating in these activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline attitudes towards covid-19 vaccines at 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline attitudes towards covid-19 vaccines at 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline attitudes towards covid-19 vaccines at 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

COVID-19 Knowledge & Attitudes (KAPs)

Coronavirus-Related eHealth Literacy Scale (CoV-eHEALS)

Rapid Testing Acceptance

+1 more

Secondary study objectives

Broadband internalizing symptoms

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Self-Affirmation Implementation Intentions (SAII) intervention (plus Promotores Health Education)Experimental Treatment2 Interventions

The SAII is designed to reduce stigma and enhance uptake of health messaging. SAII couples; (a) self-affirming interventions that focus on restoring self-integrity in the face of identity threats, with (b) implementation intention interventions focus on whether realization of goal intentions for health behaviors is facilitated by forming an "implementation intention" that spells out when, where, and how of goal striving in advance.

Group II: Promotores Health Education only conditionActive Control1 Intervention

The Promotores de Salud Health Education intervention includes: (1) a culturally tailored health education to increase knowledge about COVID-19 and the benefits of testing; (2) motivational interviewing (MI) strategies to explore personal, social, and behavioral barriers to testing and to discuss available resources to resolve these barriers; (3) emotional support to address testing-related concerns and anxieties that may dissuade Latinx individuals from getting tested; and (4) service navigation. When promotores (community health advocates) are on-site at Mexican Consulate events, they will provide information about COVID-19 and preventive behaviors using in-person instruction on effective mask wearing, hand washing, and physical distancing, as well as the importance of repeated testing and vaccines.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Behavioral interventions like the Promotores de Salud COVID-19 Health Promotion Intervention with Self-Affirming Implementation Intention (SAII) work by enhancing patients' acceptance of health messages and increasing their motivation to adopt healthier behaviors. The self-affirming component helps individuals focus on their values and strengths, which reduces resistance to health advice and lowers psychological distress. This approach is crucial for health behavior patients as it not only promotes positive behavior change but also supports mental well-being, making it more likely that patients will sustain these changes over time.

Handwashing Message Type Predicts Behavioral Intentions in the United States at the Beginning of the Global COVID-19 Pandemic.Effects of a brief multimodal online intervention on the intention to conduct sun protective behaviours through targeting illness representations about skin cancer: a randomized controlled trial.