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New treatment option for Type2diabetes
Official title Understanding and Addressing Risks of Low Socioeconomic Status and Diabetes for Heart Failure
ClinicalTrials.gov ID: NCT06364644
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 70
You may be able to join if
- Adults from Johns Hopkins Medicine (JHM) who live in Baltimore City and adults from Johns Hopkins Community Physicians (JHCP) Hagerstown or Family...
- 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)
You likely can't join if
- Age \ 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
See the full eligibility criteria
- 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)
- Age \ 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+).
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Hagerstown, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Hagerstown, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.