Type2diabetesUNLOAD-HFNCT06364644
Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
A study testing Community Champions and Homegrown Heroes in people with Type2diabetes and Heart Failure, run by Johns Hopkins University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type2diabetes, Heart Failure, Obesity
- What is being tested?
- Community Champions and Homegrown Heroes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown who live in Washington County
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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+).
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Center for Health Equity
Baltimore, Maryland, 21205
Perri Carroll, MPH, 443-692-7272, pcarro13@jhmi.edu
- Not yet recruiting
Johns Hopkins University Comstock Center
Hagerstown, Maryland, 21740
Melissa Minotti, MPH, RPSGT, CCRC
About this study
Official title: Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)
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.
Read the detailed description
This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 156 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components:
- Problem Solving - Diabetes Self-Management Training (DECIDE): Participants will engage in a biweekly evidence-based behavioral change program known as DECIDE. This program focuses on problem-solving training, aiding individuals in managing chronic conditions by overcoming obstacles and challenges. It aims to enhance self-care, improve control of metabolic risk factors, and includes tailored education on heart failure prevention.
- Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention. These workers will conduct telephone and/or home visits at least monthly, offering assistance in following areas:
- Reinforcing patient education about disease self-management
- Helping patients access care and addressing barriers to care and treatment
- Serving as facilitators and navigators to clinical care, social services, and other community resources
- Providing encouragement and support to engage, activate, and empower patients and their support systems
- Health Coaching and Partnership with Community Facilities: Participants will engage in supervised aerobic and resistance exercise training at the local Young Men's Christian Associations (YMCAs). The participants will receive instructions on gradually increasing the activity levels throughout the 6-month intervention to achieve physical activity goals (150 minutes of moderate to vigorous exercise per week).
- Conditions
- Type2diabetes, Heart Failure, Obesity
- Being tested
- Community Champions, Homegrown Heroes
- Keywords
- Behavioral Intervention, Diabetes, Heart Failure, Exercise, Obesity, Health Equity, Low Socioeconomic Status
- Medical subject headings
- Heart Failure, Obesity, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community ChampionsBehavioural
Also called Multi-level intervention
The UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs.
Homegrown HeroesBehavioural
Also called Education plus access to community exercise facility
Monthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA.
| Study group | Role | What they receive |
|---|---|---|
| Community Champions | Experimental | Participants assigned to the "Community Champions" group will undergo a six-month behavioral intervention. This intervention involves bi-weekly problem-solving training sessions (DECIDE) conducted in groups of 6-10 individuals, along with support from community health workers. Additionally, participants will receive a YMCA membership to exercise with a professional health coach. Receives: Behavioral: Community Champions |
| Homegrown Heroes | Active comparator | Participants assigned to the "Homegrown Heroes" will receive a YMCA membership for exercise and a monthly newsletters for 6 months that include education about diabetes self-management, healthy lifestyle and heart failure prevention . Receives: Behavioral: Homegrown Heroes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fitness as assessed by the 6 minute walk test
Total distance walked in the 6 minutes walk test in meters
Measured: Baseline and 6 month follow up
Secondary outcomes (17)
Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)
Percent change from baseline in hs-cTnT
Measured: Baseline and 6 month follow up
Change in hemoglobin A1c
Absolute change from baseline in hemoglobin A1c
Measured: Baseline and 6 month follow up
Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.
The following Health Problem-Solving Scale (HPSS) subscales will be assessed: Impulsive/Careless Problem Solving (IPS), Avoidant Problem Solving (APS), Negative Transfer (NTR), Negative Motivation/Orientation (NMO). Subscale scores are calculated by summing the scores for each item within the respective subscales. Higher subscale scores indicate more of that problem-solving characteristic. The score range for each subscale is as follows: IPS (0-32), APS (0-28), NTR (0-44), NMO (0-20). Total score range 0-124.
Measured: Baseline, 6 month follow up, 12 month follow up
Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)
The Summary of Diabetes Self-Care Activities Scale (SDSCA) is a tool used to measure diabetes self-care activities. 12-items with 5 sub-scales (diet, exercise, home blood glucose testing, foot care, smoking status). The respondent is asked how many days in the past week the behavior was performed (ranges from 0 to 7); The result is an average score between 0 and 7 with higher score indicating better diabetes self-management behavior.
Measured: Baseline, 6 month follow up, 12 month follow up
Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test
The Diabetes and CVD Knowledge Test comprises 16 items, featuring both multiple-choice and true-or-false questions. This assessment tool gauges individuals' comprehension of diabetes, its impact on health, and optimal strategies for managing the condition. The possible score range is 0-17. A higher score indicates a better understanding of diabetes and cardiovascular disease.
Measured: Baseline, 6 month follow up, 12 month follow up
Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)
The MPAQ is a tool used to estimate the frequency in days (number of times per month) and in time (minutes) someone participated in physical activity (e.g. biking, walking, swimming, etc.). Hours per week for all activities are summed to determine activity hours per week averaged over the past year. A higher sum indicates more physical activity. Values can also be weighted by their estimated metabolic cost and expressed as metabolic equivalent (MET) hours per week. Higher METs are associated with better outcomes.
The MPAQ also assesses inactivity, such as the average number of hours per day spent watching television or being confined to a bed or chair for more than 1 week. A higher average indicates less physical activity.
Measured: Baseline, 6 month follow up, 12 month follow up
Change in weight (kgs)
Change from baseline in weight (kgs)
Measured: Baseline and 6 month follow-up
Change in BMI
Change from baseline in BMI (Kg/m^2).
Measured: Baseline and 6 month follow-up
Change in hip and waist circumference (centimeters)
Change from baseline in hip and waist circumference (centimeters)
Measured: Baseline and 6 month follow up
Change in Metabolic Syndrome Severity Z score
Metabolic Syndrome Severity (MetS) Z score calculates an individual's metabolic syndrome severity score by examining five key markers: waist circumference, blood pressure, triglycerides, HDL, and fasting glucose. Score typically ranges from -5 to 5. Higher scores indicate greater metabolic syndrome severity.
Measured: Baseline and 6 month follow up
Change in self-management as assessed by the Patient Activation Measure (PAM-13).
The Patient Activation Measure is a 13-item survey that will assess an individual's knowledge, skills and confidence to managing one's health and healthcare. The PAM scores is calculated and then transformed to a scale with a range from 0-100. A higher PAM score indicates higher patient activation. The score can also be converted into four activation levels: 1 - not believing activation important, 2 - lack of knowledge and confidence to take action, 3 - beginning to take action, 4 - taking action.
Measured: Baseline, 6 month follow up,12 month follow up
Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
The PROMIS Global Health 10 survey comprises 10 items designed to evaluate both physical and mental health status. Scores are aggregated separately for physical and mental health, each ranging from 4 - 20. Higher scores in both categories indicate better outcomes.
Measured: Baseline, 6 month follow up,12 month follow up
Change in blood pressure (systolic and diastolic (mmHg))
changes in blood pressure from baseline
Measured: Baseline and 6 month follow up
Change in cardiac biomarker, gal-3
Percent change from baseline in gal-3
Measured: Baseline and 6 month follow up
Change in cardiac biomarkers, NT-proBNP
Percent change from baseline in NT-proBNP
Measured: Baseline and 6 month follow up
Change in post-walk Borg dyspnea scale
Changes in post-walk Borg dyspnea scale which ranges from 0 ("no shortness of breath") to 10 ("worst possible shortness of breath"); higher score worse breathing difficulty. Measured in a subset of the population.
Measured: Baseline and 6 month follow up
Change in cardiorespiratory fitness as assessed by peak oxygen uptake (V02 peak)
Change in peak oxygen uptake (VO2 peak) as assessed by a cardiopulmonary fitness test in a subset of the population.
Measured: Baseline and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start20 Jun 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design of the study is a randomized 2:1 parallel-arm clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Chiadi Ndumele, MD, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364644
- Sponsor's protocol ID
- IRB00336599
- Other IDs
- 1P50MD017348-01
- Acronym
- UNLOAD-HF
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure (UNLOAD-Heart Failure)
- ClinicalTrials.gov ID
- NCT06364644
- Acronym / sponsor ID
- UNLOAD-HF / IRB00336599
- Conditions
- Type2diabetes, Heart Failure, Obesity
- Keywords
- Behavioral Intervention, Diabetes, Heart Failure, Exercise, Obesity, Health Equity, Low Socioeconomic Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 156 individuals from Baltimore City and Hagerstown, Maryland, characterized by low neighborhood and individual socioeconomic status, type 2 diabetes, obesity, and evidence of subclinical heart dysfunction, without a prior clinical diagnosis of heart failure. The 6-month multi-level intervention consists of three key components:
- Problem Solving - Diabetes Self-Management Training (DECIDE): Participants will engage in a biweekly evidence-based behavioral change program known as DECIDE. This program focuses on problem-solving training, aiding individuals in managing chronic conditions by overcoming obstacles and challenges. It aims to enhance self-care, improve control of metabolic risk factors, and includes tailored education on heart failure prevention.
- Community Health Worker Support: Participants will receive ongoing support from community health workers as part of the intervention. These workers will conduct telephone and/or home visits at least monthly, offering assistance in following areas:
- Reinforcing patient education about disease self-management
- Helping patients access care and addressing barriers to care and treatment
- Serving as facilitators and navigators to clinical care, social services, and other community resources
- Providing encouragement and support to engage, activate, and empower patients and their support systems
- Health Coaching and Partnership with Community Facilities: Participants will engage in supervised aerobic and resistance exercise training at the local Young Men's Christian Associations (YMCAs). The participants will receive instructions on gradually increasing the activity levels throughout the 6-month intervention to achieve physical activity goals (150 minutes of moderate to vigorous exercise per week).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The design of the study is a randomized 2:1 parallel-arm clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Community Champions | Experimental | Behavioral: Community ChampionsParticipants assigned to the "Community Champions" group will undergo a six-month behavioral intervention. This intervention involves bi-weekly problem-solving training sessions (DECIDE) conducted in groups of 6-10 individuals, along with support from community health workers. Additionally, participants will receive a YMCA membership to exercise with a professional health coach. |
| Homegrown Heroes | Active comparator | Behavioral: Homegrown HeroesParticipants assigned to the "Homegrown Heroes" will receive a YMCA membership for exercise and a monthly newsletters for 6 months that include education about diabetes self-management, healthy lifestyle and heart failure prevention . |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family Healthcare of Hagerstown who live in Washington County
- 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)
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community ChampionsAlso: Multi-level interventionThe UNLOAD-Heart Failure Program intervention includes problem solving training, community health worker support, and exercise support from health coaches at YMCAs. | Behavioural | Community Champions |
| Homegrown HeroesAlso: Education plus access to community exercise facilityMonthly newsletters/videos on diabetes self-management, healthy lifestyle and heart failure prevention will be provided, as well as a membership to the local YMCA. | Behavioural | Homegrown Heroes |
Primary outcome
Change in fitness as assessed by the 6 minute walk test
Time frame: Baseline and 6 month follow up
Total distance walked in the 6 minutes walk test in meters
17 secondary outcomes
Change in cardiac biomarker, high-sensitivity cardiac troponin-T (hs-cTnT)
Time frame: Baseline and 6 month follow up
Change in hemoglobin A1c
Time frame: Baseline and 6 month follow up
Change in specific problem solving skills as assessed by Health Problem-Solving Scale (HPSS) subscales.
Time frame: Baseline, 6 month follow up, 12 month follow up
Changes in self care measures as assessed by Summary of Diabetes Self-Care Activities Scale (SDSCA)
Time frame: Baseline, 6 month follow up, 12 month follow up
Changes in disease knowledge as assessed by Diabetes and Cardiovascular Disease (CVD) Knowledge Test
Time frame: Baseline, 6 month follow up, 12 month follow up
Changes in physical activity as assessed by Modified Physical Activity Questionnaire (MPAQ)
Time frame: Baseline, 6 month follow up, 12 month follow up
Change in weight (kgs)
Time frame: Baseline and 6 month follow-up
Change in BMI
Time frame: Baseline and 6 month follow-up
Change in hip and waist circumference (centimeters)
Time frame: Baseline and 6 month follow up
Change in Metabolic Syndrome Severity Z score
Time frame: Baseline and 6 month follow up
Change in self-management as assessed by the Patient Activation Measure (PAM-13).
Time frame: Baseline, 6 month follow up,12 month follow up
Change in quality of life and overall health and well-being as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
Time frame: Baseline, 6 month follow up,12 month follow up
Change in blood pressure (systolic and diastolic (mmHg))
Time frame: Baseline and 6 month follow up
Change in cardiac biomarker, gal-3
Time frame: Baseline and 6 month follow up
Change in cardiac biomarkers, NT-proBNP
Time frame: Baseline and 6 month follow up
Change in post-walk Borg dyspnea scale
Time frame: Baseline and 6 month follow up
Change in cardiorespiratory fitness as assessed by peak oxygen uptake (V02 peak)
Time frame: Baseline and 6 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chiadi Ndumele, MD, PhD principal investigator
Johns Hopkins School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Champions and Homegrown Heroes in people with Type2diabetes and Heart Failure, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiadi Ndumele, MD, PhD (4105022319, cndumel2@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fitness as assessed by the 6 minute walk test (time frame: Baseline and 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.