Obesity Clinical Trial - Understanding & Addressing Risks of Low

Status Not yet recruiting

Clinical 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 receiving education and access to a community exercise facility.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06364644
Study type	Interventional
Source	Johns Hopkins University
Contact	Chiadi Ndumele, MD, PhD
Phone	4105022319
Email	cndumel2@jhmi.edu
Status	Not yet recruiting
Phase	N/A
Start date	May 2024
Completion date	June 30, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms