Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT06286618
Brief Summary:
The objective for the study is to implement a pilot study to establish essential components to address diet quality in healthcare settings and examine what value an integrated service model delivery has for the primary prevention of cardiometabolic diseases with an initial focus on dietary behaviors. This objective will be met by 1: Utilizing a multiphase optimization study design to select and optimize essential components to address diet behaviors and 2: Comparing an integrated and referral-based delivery model for healthcare-based strategies that address structural and psychosocial barriers to a healthy diet for racial/ethnic minority, marginalized and disadvantaged background young to middle aged adult populations in Mississippi.
Detailed Description:
The study is designed based on the multiphase optimization strategy (MOST), which includes three phases to prepare or screen, optimize, and evaluate multiple components of an intervention. During first optimization phase, study team will conduct essential component selection by pilot testing three common strategies used in healthcare settings to deliver structural and psychosocial interventions that address diet behaviors. The second optimization phase will include pilot testing to examine the optimization of delivery mode for the essential components identified in first phase. In each phase, participants between 25 to 50 years of age who are at risk for CVD-related premature mortality will be recruited to complete a 3-month intervention in a community based clinical setting in Mississippi. The proposed project will provide foundational knowledge for components and delivery models that are the most essential and cost-effective to improve dietary behaviors among racial/ethnic minority and disadvantaged background populations in Mississippi.
Study:
NCT06286618
Study Brief:
Protocol Section:
NCT06286618