RECRUITING

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure

Conditions

Type2diabetes Heart Failure Obesity Behavioral Intervention Diabetes Exercise Health Equity Low Socioeconomic Status

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to determine whether a 6-month multilevel intervention involving problem-solving training, exercise training and support from community health workers is more effective in improving outcomes for individuals with low socioeconomic status, type 2 diabetes, obesity, and early cardiac dysfunction than receiving education and access to a community exercise facility.

Official Title

Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)

Quick Facts

Study Start:2024-07-16

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06364644

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.

Ages Eligible for Study:30 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Meritus Medical Center (MMC) or Family Healthcare of Hagerstown who live in Hagerstown. * Low socioeconomic status (SES) by high Area Deprivation Index (ADI) \[\>75th percentile for the state of Maryland\] plus low income) * Type 2 diabetes * Obesity (BMI≥30 kg/m\^2) * Evidence of cardiac dysfunction (by echocardiogram or elevated NT-proBNP \[≥125 pg/ml\])	* Age \< 30 or \>70 years * Prevalent heart failure * Uncontrolled glycemia (blood glucose \<60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%) * Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications) * Known coronary artery disease (unless \< 50% stenosis by angiography) * Moderate or severe valvular heart disease * Serious medical conditions limiting life expectancy or requiring active management * Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+). * Weight loss of ≥ 5% in the past year or current use of weight loss medications * Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week * End stage renal disease * Current participation in another behavior change program * Active alcohol or substance abuse disorder * Already engaging in regular exercise with more than 60 minutes of moderate \[3-6 METS\] to vigorous \[\>6 METS\] physical activity per week * Active pregnancy * Evidence of ischemia, dangerous arrhythmia or other clinical instability on baseline exercise stress test

Inclusion Criteria

Exclusion Criteria

* Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Meritus Medical Center (MMC) or Family Healthcare of Hagerstown who live in Hagerstown.
* Low socioeconomic status (SES) by high Area Deprivation Index (ADI) \[\>75th percentile for the state of Maryland\] plus low income)
* Type 2 diabetes
* Obesity (BMI≥30 kg/m\^2)
* Evidence of cardiac dysfunction (by echocardiogram or elevated NT-proBNP \[≥125 pg/ml\])

* Age \< 30 or \>70 years
* Prevalent heart failure
* Uncontrolled glycemia (blood glucose \<60 mg/d or ≥ 300 mg/dl or most recent hemoglobin A1c ≥11%)
* Uncontrolled blood pressure (Systolic blood pressure (SBP) ≥160 or diastolic blood pressure (DBP) ≥100 mm Hg, either on or off medications)
* Known coronary artery disease (unless \< 50% stenosis by angiography)
* Moderate or severe valvular heart disease
* Serious medical conditions limiting life expectancy or requiring active management
* Inability to participate in moderate intensity physical activity as assessed by the self-report Physical Activity Readiness Questionnaire Plus (PAR-Q+).
* Weight loss of ≥ 5% in the past year or current use of weight loss medications
* Any condition or planned surgery/procedure precluding exercise for ≥ 150 minutes per week
* End stage renal disease
* Current participation in another behavior change program
* Active alcohol or substance abuse disorder
* Already engaging in regular exercise with more than 60 minutes of moderate \[3-6 METS\] to vigorous \[\>6 METS\] physical activity per week
* Active pregnancy
* Evidence of ischemia, dangerous arrhythmia or other clinical instability on baseline exercise stress test

Contacts and Locations

Study Contact

Chiadi Ndumele, MD, PhD

CONTACT

4105022319

cndumel2@jhmi.edu

Perri Carroll, MPH

CONTACT

4436927272

pcarro13@jhmi.edu

Principal Investigator

Chiadi Ndumele, MD, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Study Locations (Sites)

Johns Hopkins Center for Health Equity

Baltimore, Maryland, 21205

United States

Johns Hopkins University Comstock Center

Hagerstown, Maryland, 21740

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Chiadi Ndumele, MD, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins School of Medicine

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 Registration Dates

Study Start Date2024-07-16

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2024-07-16

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

Behavioral Intervention
Diabetes
Heart Failure
Exercise
Obesity
Health Equity
Low Socioeconomic Status

Additional Relevant MeSH Terms

Type2diabetes
Heart Failure
Obesity