Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians

University of Southern Mississippi

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Other: Integrated Psychosocial+Structural; Other: Traditional Psychosocial+Structural; Other: Structural Intervention; Behavioral: Psychosocial Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06286618

HHSN268201800015I (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

24 participants in 2 patient groups

Psychosocial or Structural Intervention

Experimental group

Description:

During optimization 1 phase, participants are assigned to two groups: Psychosocial or Structural Intervention. One group will receive psychosocial support for diet only and the other will receive structural support for diet only. Each group will have three modalities.

Treatment:

Behavioral: Psychosocial Intervention

Other: Structural Intervention

Combined Psychosocial and Structural Intervention

Experimental group

Description:

The optimization 2 phase will be used to test a combined psychosocial and structural intervention, based on the most feasible selections from optimization 1 phase.During optimization 2 phase, participants will be assigned to two groups. One group will receive referral based delivery model for a combined psychosocial and structural intervention and the other group will receive an integrated delivery model for a combined psychosocial and structural intervention.

Treatment:

Other: Traditional Psychosocial+Structural

Other: Integrated Psychosocial+Structural