Clinical trial NCT06286618: Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
Official title: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
Collaborators: name: My Brother's Keeper
First posted: 2024-02-29
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 25 to 50 years of age
* cardiovascular disease-related premature mortality risk (people living with HIV/AIDS or diagnosed with or familial risk for diabetes, hypertension, obesity, or Metabolic syndrome)
* internet access
* Jackson (Mississippi) metropolitan statistical area residency

Exclusion Criteria:

* cancer with active treatment
* chronic obstructive pulmonary disorder, emphysema, cystic fibrosis or any other major lung disease
* liver or kidney dysfunction, end-stage renal disease, active hepatitis,
* celiac disease, colitis, or other gastrointestinal disorders
* current pregnancy or within six months postpartum at baseline
* heavy drinking
* unintentional weight loss of more than 5% of body weight within the past six months
* recent (in the past 6 months) heart attack, stroke or other major heart surgery or event
* eating disorders (anorexia or bulimia nervosa)
* currently being treated for a fungus, bacteria, viral, or other infection due to weak immune system
* Insulin dependent diabetes

Primary outcomes:
measure: Participant Burden
timeFrame: up to 12 weeks
Secondary outcomes:
measure: cost effectiveness
timeFrame: 3 months
measure: session attendance
timeFrame: 3 months
measure: diet quality
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Hattiesburg
country: United States
facility: The University of Southern Mississippi
state: Mississippi
Study officials:
affiliation: My Brother's Keeper, Inc.
name: June Gipson, PhD
role: PRINCIPAL_INVESTIGATOR
References: