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

Johns Hopkins University

Status: Enrolling

Conditions: Type2diabetes; Obesity; Heart Failure

Treatments: Behavioral: Community Champions; Behavioral: Homegrown Heroes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06364644

1P50MD017348-01 (U.S. NIH Grant/Contract)

IRB00336599

Details and patient eligibility

About

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.

Full description

This randomized controlled trial employs a 2:1 allocation ratio. The study aims to include 402 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:

1. 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.

2. 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

3. 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).

Enrollment: 210 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Community Champions

Experimental group

Description:

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.

Treatment:

Behavioral: Community Champions

Homegrown Heroes

Active Comparator group

Description:

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 .

Treatment:

Behavioral: Homegrown Heroes