Community Health Promotion for Reducing Health Disparities

(CEAL-DMV Trial)

Recruiting at 2 trial locations

Overseen By Cheryl Himmelfarb, PhD, MSN, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: No phone/internet, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

664 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a health promotion program designed to reduce health disparities in Black and Latino communities. Participants receive coaching and resources through a digital platform to support behavior changes related to prediabetes, diabetes, high blood pressure, and obesity. The trial compares an active group receiving community and digital support with a control group receiving educational content and event recommendations. Individuals who self-identify as Black or Latino, have access to a phone or internet, and have conditions like prediabetes, diabetes, high blood pressure, or obesity are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to contribute to important research aimed at improving community health.

Will I have to stop taking my current medications?

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

What prior data suggests that this multi-level, community-digital health promotion intervention is safe?

Research has shown that digital health tools, like those used in this trial, can make healthcare more accessible and less expensive. Although specific safety data for this exact tool is not available, digital health programs are generally considered safe. They typically involve technology and community support to encourage healthier choices.

Studies have examined how digital health tools can change behaviors without major risks. Users often report few issues, usually related to ease of use rather than health risks. This trial employs community health workers and digital platforms to guide health changes, emphasizing support and information over medical treatments, which generally results in low safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multi-level, community-digital health promotion intervention because it offers a comprehensive approach to reducing health disparities. Unlike traditional treatments that might focus on just medication or individual counseling, this intervention integrates community and individual support with digital resources. It uniquely combines community health worker coaching, personalized social media cues, and recommendations for local social network activities, like visiting parks or joining peer groups. This multifaceted strategy not only aims to change individual behavior but also leverages community resources and digital platforms to support lasting health improvements.

What evidence suggests that this multi-level, community-digital health promotion intervention is effective for reducing health disparities?

Research has shown that using multiple approaches can effectively tackle health differences, especially in minority communities. More than half of the studies on community-based programs have demonstrated success in reducing these health gaps. In this trial, participants in the multi-level, community-digital health promotion intervention arm will receive a combination of community support, personal coaching, and digital tools. Digital health tools, like those used in this program, promise to improve access to care and reduce healthcare costs. These tools can also help overcome challenges such as staff shortages. By combining these elements, the program aims to build trust and encourage healthier habits. ^{2 3 6 7 8}

Who Is on the Research Team?

Cheryl Himmelfarb, PhD, MSN, BS

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with conditions like diabetes, prediabetes, high blood pressure, or obesity. It's focused on communities in the Washington DC, Maryland, and Virginia areas. Participants should be interested in a digital health promotion intervention that involves their community.

Inclusion Criteria

Self-identify as Black or Latino

Reside in defined geographic area

I have been diagnosed with prediabetes/diabetes, hypertension, or I am overweight/obese.

Exclusion Criteria

No access to phone/internet

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multi-level, community-digital health promotion intervention, including CHW-delivered coaching and digital resources

12 months

Regular interactions with community health workers and digital platform access

Follow-up

Participants are monitored for health outcomes such as HbA1c levels, BMI, and blood pressure

6-9 months

Delayed Control Intervention

Participants receive a standardized 12-month text message campaign and educational content

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Multi-level, community-digital health promotion intervention

Trial Overview The trial tests a multi-level community-digital health promotion intervention designed to reduce health disparities related to diabetes, prediabetes, high blood pressure, and obesity through improved communication and trust within the community.

How Is the Trial Designed?

Group I: Multi-level, community-digital health promotion intervention Experimental Treatment 1 Intervention

Participants will receive a multi-level, community-digital health promotion intervention. 1. Community-level: Community Health Workers will assess needs of individuals including through a survey and facilitate access to the Medi digital resource platform. 2. Individual level: CHW-delivered coaching on behavior-change goals and facilitation to services via the Medi platform. Participants will also receive tailored social media and in person reinforcements and cues to action based on goal attainment 3. Social network level: Participants will receive tailored recommendations sent via social media on nearby parks, recreational facilities, faith-based ministries, and peer groups to support behavior change goals

Group II: Delayed control intervention group Active Control 1 Intervention

At the individual level, participants will receive standardized 12-month text message (SMS) campaign. At the community-level, the investigators will equip community-based organization partners and community health workers with chronic disease educational content. Participants will also receive recommendations for health events and fairs locally.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

La Clinica del Pueblo

Collaborator

Trials

1

Recruited

660+

Coaching Salud Holistica

Collaborator

Trials

1

Recruited

660+

The Medi Inc.

Collaborator

Trials

1

Recruited

660+

Baltimore CONNECT

Collaborator

Trials

1

Recruited

660+

Rivera Group

Collaborator

Trials

1

Recruited

660+

Westat

Collaborator

Trials

49

Recruited

39,700+

Published Research Related to This Trial

The study involved 86 participants who contributed to the development of tailored notifications for a mobile health intervention aimed at reducing sodium intake and increasing physical activity to lower blood pressure.

Community-generated notifications were found to be more effective, using direct and relatable language, while also addressing specific cultural and social needs, highlighting the importance of incorporating local perspectives in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community Participatory Approach to Creating Contextually Tailored mHealth Notifications: myBPmyLife Project. Hellem, AK., Casetti, A., Bowie, K., et al.[2023]

The study demonstrated the feasibility of a multidisciplinary intervention using health coach-facilitated virtual visits and a cloud-based glucose monitoring system to improve access to care for uninsured, poorly-controlled diabetic patients, with 100% participant satisfaction in recommending the intervention.

Participants in the intervention group had significantly more documented contacts with patient-centered medical home (PCMH) providers (median of nine) compared to the control group (median of four), suggesting enhanced chronic disease management through the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial. Emerson, JF., Welch, M., Rossman, WE., et al.[2018]

Digital health interventions have the potential to improve care for chronic diseases by providing accessible and personalized support, but they may also unintentionally increase health inequities among marginalized groups.

To effectively reduce health disparities, it is crucial to develop context-specific digital health solutions, foster partnerships across sectors, and actively involve historically marginalized communities in the design and implementation of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying a Social Determinants of Health Framework to Guide Digital Innovations That Reduce Disparities in Chronic Disease. Goldstein, SP., Tovar, A., Espel-Huynh, HM., et al.[2023]

The digital divide in consumer information technologies has decreased, allowing for greater use of mobile health (mHealth), telehealth, and social media to improve access to health interventions for underserved populations.

Despite the potential of CIT-enabled interventions, the evidence supporting their effectiveness in health disparity populations is still developing, highlighting the need for better design, evaluation, and inclusive practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Interventions Using Consumer Information Technology as Tools to Advance Health Equity. Bakken, S., Marden, S., Arteaga, SS., et al.[2020]

Underserved groups often do not benefit equally from eHealth interventions due to usability issues and broader barriers to technology adoption, highlighting the need for tailored solutions.

The authors identified five key principles for designing effective eHealth interventions for underserved populations, including addressing communication inequalities, engaging stakeholders, ensuring usability, protecting privacy, and balancing open science with participant protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Effective eHealth Interventions for Underserved Groups: Five Lessons From a Decade of eHealth Intervention Design and Deployment. Lee, EW., McCloud, RF., Viswanath, K.[2022]

In Mississippi, nearly half of adults (46.8%) consume sugar-sweetened beverages (SSBs) at least once a day, with those having lower health literacy (HL) being 1.7 times more likely to consume SSBs compared to those with higher HL.

Adults who do not use or notice menu labeling (ML) at fast-food restaurants are significantly more likely to consume SSBs, with nonusers having 2.3 times the odds of daily SSB consumption compared to ML users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of Health Literacy and Menu-Labeling Usage With Sugar-Sweetened Beverage Intake Among Adults in Mississippi, 2016. Lee, SH., Zhang, L., Rubin, DL., et al.[2022]

Digital and mobile health (mHealth) interventions have been shown to effectively improve health outcomes for minority patients suffering from chronic conditions like diabetes, congestive heart failure, and chronic respiratory diseases.

The paper highlights various electronic and digital strategies, such as telephones and mobile platforms, that have been implemented to enhance chronic disease management, particularly focusing on their impact on racial and ethnic minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to Improve Management of Chronic Conditions Among Racial and Ethnic Minorities. Doshi, R., Aseltine, RH., Sabina, AB., et al.[2021]

The SIPsmartER intervention, which lasted 6 months and involved 155 participants, effectively reduced sugary beverage intake among rural, low socioeconomic adults, with high satisfaction ratings across all components of the program.

Participants with varying health literacy levels reported similar satisfaction with the intervention, indicating that a health literacy universal precautions approach is effective and acceptable for both high and low health literacy groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of health literacy on rural adults' satisfaction with a multi-component intervention to reduce sugar-sweetened beverage intake. Bailey, AN., Porter, KJ., Hill, JL., et al.[2019]

A CME program was developed to improve primary care physicians' skills in communicating cancer risks and facilitating shared decision-making with patients who have low health literacy, involving 18 physicians and 73 patients in a cluster randomized controlled trial.

Baseline assessments revealed that while physicians felt confident in their communication skills, patients reported feeling poorly involved in decision-making, highlighting a significant gap that the training aims to address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer risk communication with low health literacy patients: a continuing medical education program. Price-Haywood, EG., Roth, KG., Shelby, K., et al.[2021]

A co-design process involving 16 participants (8 patients with atrial fibrillation and 8 clinicians) led to the development of a digital health intervention that addresses key challenges such as medication adherence and patient education.

The intervention incorporates user-generated ideas focused on risk factor modification and remote management of atrial fibrillation episodes, demonstrating a human-centered approach that can enhance engagement and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Virtual Inclusive Digital Health Intervention Design to Promote Health Equity (iDesign) Framework for Atrial Fibrillation: Co-design and Development Study. Isakadze, N., Molello, N., MacFarlane, Z., et al.[2022]

Current digital health solutions have not effectively reached diverse user groups or addressed health inequities, highlighting a need for more inclusive approaches.

The paper proposes a multilevel framework for digital health equity and identifies five promising intervention types, suggesting that future efforts should focus on improving policies and practices to enhance access and effectiveness for all individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel Determinants of Digital Health Equity: A Literature Synthesis to Advance the Field. Lyles, CR., Nguyen, OK., Khoong, EC., et al.[2023]

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