SanaMente: A Peer-Led Program to Reduce Health Disparities in Rural Latino/a Communities (SanaMente)

July 10, 2026 updated by: Anahí Collado, University of Colorado, Boulder

SanaMente: A Peer-Led, Evidence-Based Mental Health and Lifestyle Program to Reduce Health Disparities in Rural Latino/a Communities

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are:

  • Is the SanaMente program feasible and acceptable for rural Latino/a adults with chronic medical conditions and mental health concerns?
  • Does participation in the SanaMente program improve mental health outcomes (depression, anxiety, and stress), healthy lifestyle behaviors (sleep, physical activity, and nutrition), and overall well-being?

This is a single-arm pilot study without comparison group.

Participants will:

  • Participate in the 6-8 week SanaMente peer-led group program.
  • Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction.
  • Complete an exit survey and have the option to participate in a focus group to provide feedback on the program's usability, acceptability, perceived impact, and suggestions for improvement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This Stage IB feasibility and pilot study is designed to refine and evaluate the SanaMente program, a culturally tailored, peer-led intervention developed to address the intersecting mental and physical health needs of rural Latinx adults living with chronic medical conditions. The study will assess implementation processes and generate preliminary evidence to inform a future, fully powered efficacy trial.

The intervention will be delivered by bilingual peer mentors who will receive standardized training prior to facilitating small group sessions. Throughout the study, implementation outcomes-including recruitment, retention, attendance, intervention fidelity, and participant engagement-will be monitored to evaluate the practicality of delivering the program in rural community settings.

A mixed-methods evaluation will be used to examine both implementation and participant outcomes. Quantitative analyses will estimate changes in mental health symptoms, health behaviors, and overall well-being over the course of the intervention, with effect size estimates used to inform the design and sample size of future studies. Qualitative data collected from participant feedback will be analyzed to identify factors influencing program engagement, perceived benefits, barriers to participation, and recommendations for improving program content and delivery.

Study findings will be used to optimize the SanaMente intervention, enhance its cultural relevance and implementation strategies, and establish the feasibility of conducting a larger randomized controlled trial to evaluate its effectiveness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Carbondale, Colorado, United States, 81623
        • Recruiting
        • La Clinica del Pueblo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Identify as Hispanic/Latino/a.
  • Patients of La Clínica del Pueblo in Carbondale, Colorado.
  • Spanish-speaking (bilingual Spanish-English speakers are eligible).
  • Interest in improving your physical and emotional well-being.
  • Are currently managing or are at risk for chronic medical or metabolic conditions (e.g., diabetes, cardiovascular disease, liver, or kidney conditions), but a diagnosis is not required.
  • Experiencing or at risk for stress, low mood, or anxiety (formal diagnosis not required)
  • Willingness and ability to participate in the SanaMente program.
  • Willing to provide a release of information authorizing study staff to communicate with La Clínica del Pueblo in the event that a participant endorses suicidality or if it becomes necessary to share relevant medical information to ensure participant safety and appropriate care.

Exclusion Criteria:

  • Individuals who are unable to provide informed consent.
  • Individuals who are unwilling or unable to participate in the group-based or one-to-one SanaMente sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SanaMente Program
This is a single-arm, open-label study in which all participants receive the SanaMente intervention. Participants will be enrolled into peer-led groups of approximately 6-10 individuals and will complete the 6-8 week program.
Behavioral: SanaMente
SanaMente is a culturally responsive, peer-led behavioral program designed to support mental health and promote healthy lifestyle behaviors among rural Latino/a adults with chronic medical conditions and mental health concerns. The program is delivered by trained bilingual peer mentors in small group sessions over 6-8 weeks and integrates evidence-based strategies to improve depression, anxiety, stress, sleep, physical activity, nutrition, and overall well-being. The intervention emphasizes culturally relevant content, peer support, and skill-building to enhance self-management and emotional wellness.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Change in total score from baseline to post-program will be evaluated.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Change in total score from baseline to post-program will be evaluated.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Body Weight
Time Frame: Baseline and Post-Program (week6-8)
Body weight will be measured in kilograms (kg) using a calibrated digital scale following standardized clinical procedures. Change in body weight from baseline to post-program will be evaluated.
Baseline and Post-Program (week6-8)
Systolic Blood Pressure
Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures. Change from baseline to post-program will be evaluated.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Diastolic Blood Pressure
Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Resting Heart Rate
Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Resting heart rate will be measured in beats per minute (bpm) using standardized clinical procedures.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Glycemic control as assessed by Hemoglobin A1c (HbA1c)
Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
HbA1c will be measured from a blood sample as an indicator of average blood glucose over the previous 2-3 months. Values are reported as percentage (%).
Changes from Baseline and Post-Program (week6-8) will be evaluated
Total Cholesterol
Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Fasting total cholesterol will be measured in mg/dL.
Changes from baseline to post-program (week 6-8) will be evaluated.
LDL Cholesterol
Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting low-density lipoprotein (LDL) cholesterol will be measured in mg/dL.
Changes from Baseline and Post-Program (week6-8) will be evaluated
HDL Cholesterol
Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Triglycerides
Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting triglycerides will be measured in mg/dL.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Alanine aminotransferase (ALT)
Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Alanine aminotransferase (ALT) will be assessed in fasting blood samples and reported in U/L. ALT is a marker of hepatocellular injury.
Changes from baseline to post-program (week 6-8) will be evaluated.
Electrolytes
Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Electrolyte balance will be assessed using serum sodium (mEq/L), potassium (mEq/L), and chloride (mEq/L), obtained from fasting blood samples. These measures reflect systemic fluid and electrolyte homeostasis.
Changes from baseline to post-program (week 6-8) will be evaluated.
Metabolic Function
Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Metabolic function will be assessed using fasting plasma glucose (mg/dL), obtained from fasting blood samples as an indicator of glycemic status..
Changes from baseline to post-program (week 6-8) will be evaluated.
Aspartate aminotransferase (AST)
Time Frame: Changes from Baseline to Post-program (week 6-8) will be evaluated
Aspartate aminotransferase (AST) will be assessed in fasting blood samples and reported in U/L. AST is a marker of hepatocellular injury.
Changes from Baseline to Post-program (week 6-8) will be evaluated
Total bilirubin
Time Frame: Changes from Baseline to post-program (week 6-8) will be evaluated
Total bilirubin will be assessed in fasting blood samples and reported in mg/dL. Total bilirubin is a marker of hepatic excretory function.
Changes from Baseline to post-program (week 6-8) will be evaluated
Serum albumin
Time Frame: Changes from Baseline to post-program (week 6-8) will be evaluated
Serum albumin will be assessed in fasting blood samples and reported in g/dL. Serum albumin is a marker of hepatic synthetic function and nutritional status.
Changes from Baseline to post-program (week 6-8) will be evaluated
Serum creatinine
Time Frame: Changes from Baseline to post-program (week 6-8) will be evaluated
Serum creatinine will be assessed in fasting blood samples and reported in mg/dL. Serum creatinine is a marker of glomerular filtration and renal function.
Changes from Baseline to post-program (week 6-8) will be evaluated
Blood urea nitrogen (BUN)
Time Frame: Changes from Baseline to post-program (weeks 6-8) will be evaluated
Blood urea nitrogen (BUN) will be assessed in fasting blood samples and reported in mg/dL. BUN is a marker of renal function and protein metabolism.
Changes from Baseline to post-program (weeks 6-8) will be evaluated

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived stress as assessed by the Perceived Stress Scale (PSS-10)
Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Perceived Stress Scale-10 (PSS-10). The PSS-10 is a 10-item self-report measure that assesses the degree to which situations in one's life are appraised as stressful during the past month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. Change in total PSS-10 score from baseline to post-program will be evaluated.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Behavioral activation as assessed by the Behavioral Activation for Depression Scale-Short Form (BADS-SF)
Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Behavioral Activation for Depression Scale-Short Form (BADS-SF). The BADS-SF is a self-report measure of behavioral activation and avoidance associated with depression. Total scores range from 0 to 54, with higher scores indicating greater behavioral activation. Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Disability and functioning as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; 12-item, self-administered version). The WHODAS 2.0 is a 12-item self-report measure assessing disability and functioning across six domains of daily life. Total scores range from 0 to 48 using simple scoring, with higher scores indicating greater disability. Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
Time Frame: Baseline, mid program (week 3-4), post-program (week 6-8)
International Physical Activity Questionnaire (IPAQ; Short Form). The IPAQ is a validated self-report instrument designed to assess health-related physical activity across countries. The short form includes 4 items assessing frequency and duration of vigorous activity, moderate activity, walking, and sitting during the last 7 days. Physical activity will be summarized as total metabolic equivalent (MET)-minutes per week. Higher values indicate greater physical activity.
Baseline, mid program (week 3-4), post-program (week 6-8)
Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ)
Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Dietary Screener Questionnaire (DSQ). The DSQ is a self-report instrument developed to assess dietary intake patterns over the past 30 days, including frequency of consumption of fruits, vegetables, fiber, whole grains, dairy, added sugars, and other dietary components. The DSQ is used to estimate intake of specific food groups rather than generate a single total score. Higher estimated values indicate greater consumption of the respective dietary components being assessed.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS)
Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Everyday Discrimination Scale (EDS). The EDS is a self-report measure assessing the frequency of routine experiences of unfair treatment and discrimination in daily life. The standard scale includes multiple items rated on a Likert-type frequency scale, with response options typically ranging from "never" to "almost every day." Total scores are calculated by summing item responses, with higher scores indicating greater perceived discrimination.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Post-program (weeks 6-8)
Participant satisfaction with the SanaMente program will be assessed using the Client Satisfaction Questionnaire (CSQ-8). Higher scores indicate greater satisfaction with the program and services received.
Post-program (weeks 6-8)
Program usability and acceptability
Time Frame: Post-program (week 6-8)
Participants will complete an investigator-developed exit survey assessing the program's usability, cultural relevance, perceived impact, and recommendations for improvement.
Post-program (week 6-8)
Participant demographic Characteristics
Time Frame: baseline
Demographic information, including age, sex, gender identity, education, country of origin, language preference, employment status, and other background characteristics, will be collected to describe the study population and explore associations with study outcomes.
baseline
Suicide risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Screener
Time Frame: As clinically indicated throughout study participation (baseline, mid-program week 3-4, and post-program week 6-8)
Suicide risk will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) Screener to identify suicidal ideation and behaviors and facilitate appropriate safety referrals when indicated. This is a safety assessment and not an efficacy outcome.
As clinically indicated throughout study participation (baseline, mid-program week 3-4, and post-program week 6-8)
Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Alcohol use will be assessed among participants who endorse current alcohol use using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a validated 10-item self-report questionnaire that assesses hazardous and harmful alcohol consumption and alcohol-related problems.
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Drug Use Disorders Identification Test (DUDIT)
Time Frame: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Drug use will be assessed among participants who endorse current drug use using the Drug Use Disorders Identification Test (DUDIT). The DUDIT is a validated self-report questionnaire that assesses the frequency and severity of drug use and drug-related problems.
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Fagerström Test for Nicotine Dependence (FTND)
Time Frame: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Nicotine dependence will be assessed among participants who endorse current tobacco or nicotine use using the Fagerström Test for Nicotine Dependence (FTND). The FTND is a validated self-report questionnaire that assesses the severity of nicotine dependence.
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Boulder

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
La Clinica del Pueblo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anahi Collado, PhD, University of Colorado, Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-0557
  • 2025*1053 (Other Grant/Funding Number: Colorado Department of Public Health and Environment Health Disparities and Community Grant Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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