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

NCT06286618 | Completed

• 1 other identifier: HHSN268201800015I
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Participant Burden

  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.

  up to 12 weeks

Secondary Outcomes (3)

• cost effectiveness

  3 months

• session attendance

  3 months

• diet quality

  up to 3 months

Study Arms (2)

Psychosocial or Structural Intervention

EXPERIMENTAL

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.

Behavioral: Psychosocial Intervention; Other: Structural Intervention

Combined Psychosocial and Structural Intervention

EXPERIMENTAL

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.

Other: Traditional Psychosocial+Structural; Other: Integrated Psychosocial+Structural

Interventions

Psychosocial Intervention BEHAVIORAL

Psychosocial intervention is an intensive behavioral therapy intervention to address dietary behaviors. Each intervention session is a one-on-one interaction that focuses on setting individualized dietary goals and following up on them and is delivered by trained personnel. Sessions are delivered in 3 modalities which include face-to-face, phone call, and telehealth delivery. Each participant is randomly assigned to receive 4 weeks of each modality in one of the following orders: 1) Face-to-face; Telehealth; Phone Call 2) Telehealth; Phone Call; Face-to-face 3) Phone call; Face-to-face; Telehealth.

Psychosocial or Structural Intervention

Structural Intervention OTHER

The structural intervention is designed to supplement the diet with food resources via three modalities: voucher-based or F/V prescription, home meal delivery, or food bank box program. The voucher-based model includes a weekly $50 gift card with a prescription for having to eat more fruits and vegetables. The home meal delivery model includes a meal subscription that supplements the diet with two meals for two people each week (four total servings worth $65 including shipping). The food bank box program consists of participants picking up a box of food weekly from a food pantry located in the outpatient clinic. Each participant is randomly assigned to receive 4 weeks of each modality in one of the following orders: 1) Voucher; Meal Delivery; Food Box 2) Meal Delivery; Food Box; Voucher 3) Food Box; Voucher; Meal Delivery.

Psychosocial or Structural Intervention

Traditional Psychosocial+Structural OTHER

Participants will receive a combination of psychosocial and structural intervention, based on the most feasible selections from the preparation phase of the study. The intervention will initiate in a referral-based fashion in which participants will receive referral at enrollment visit.

Combined Psychosocial and Structural Intervention

Integrated Psychosocial+Structural OTHER

Participants will receive a combination of psychosocial and structural intervention, based on the most feasible selections from the preparation phase of the study. The intervention will initiate in an integrated fashion in which participants will receive immediate onboard at enrollment visit.

Combined Psychosocial and Structural Intervention

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Mississippi: lead
• My Brother's Keeper, Inc.: collaborator

Study Sites (1)

The University of Southern Mississippi

Hattiesburg, Mississippi, 39406-0001, United States

Location

Related Publications (1)

• Lemacks JL, Greer T, Aras S, Holbrook S, Gipson J. Multiphase optimization strategy to establish optimal delivery of nutrition-related services in healthcare settings: A step towards clinical trial. Contemp Clin Trials. 2024 Nov;146:107683. doi: 10.1016/j.cct.2024.107683. Epub 2024 Sep 3.

  PMID: 39236781 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• June Gipson, PhD

  My Brother's Keeper, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 29, 2024
• Study Start: September 1, 2022
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)