Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
- Conditions
- Cardiovascular Diseases
- Interventions
- Behavioral: Psychosocial InterventionOther: Traditional Psychosocial+StructuralOther: Structural InterventionOther: Integrated Psychosocial+Structural
- Registration Number
- NCT06286618
- Lead Sponsor
- University of Southern Mississippi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Psychosocial or Structural Intervention Structural Intervention 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. Psychosocial or Structural Intervention Psychosocial Intervention 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. Combined Psychosocial and Structural Intervention Integrated Psychosocial+Structural 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. Combined Psychosocial and Structural Intervention Traditional Psychosocial+Structural 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.
- Primary Outcome Measures
Name Time Method Participant Burden up to 12 weeks An existing validated tool designed to assess research participant burden (Lingler et al., 2014) for cultural and contextual appropriateness; the tool includes 21 items assessed on a 5-point Likert agreement scale and the final adapted items will be summed for a total score. Higher scores mean a worse outcome.
- Secondary Outcome Measures
Name Time Method cost effectiveness 3 months Cost factors were identified by the study team during the preparation phase and measured based on personnel time, commodities, and other relevant factors for the delivery of the intervention components. Effects will then be computed based on the physical burden to determine the cost-effectiveness ratio.
session attendance 3 months Participant are expected to attend 12 intervention sessions over the course of 3 months. Attendance will be recorded by the participant manager as a categorical variable (yes/no). Higher attendance will mean a better outcome.
diet quality up to 3 months Dietary intake will be assessed using the NHANES Dietary Screener Questionnaire, which is a validated food frequency questionnaire assessing food intake over the past month. Participants will be asked to complete this at baseline, month 1, month 2, and post program. Increases in consumption of foods such as fruits, vegetables, whole grains, dairy/calcium and decreases in added sugars, red meat, and processed meat will mean a better outcome.
Trial Locations
- Locations (1)
The University of Southern Mississippi
🇺🇸Hattiesburg, Mississippi, United States