Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
NCT ID: NCT06286618
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2022-09-01
2024-09-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Psychosocial or 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 Intervention
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.
Structural Intervention
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.
Combined Psychosocial and Structural Intervention
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.
Traditional Psychosocial+Structural
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.
Integrated Psychosocial+Structural
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.
Interventions
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Psychosocial Intervention
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.
Structural Intervention
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.
Traditional Psychosocial+Structural
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.
Integrated Psychosocial+Structural
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
50 Years
ALL
Yes
Sponsors
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My Brother's Keeper
UNKNOWN
University of Southern Mississippi
OTHER
Responsible Party
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Principal Investigators
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June Gipson, PhD
Role: PRINCIPAL_INVESTIGATOR
My Brother's Keeper, Inc.
Locations
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The University of Southern Mississippi
Hattiesburg, Mississippi, United States
Countries
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References
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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.
Other Identifiers
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HHSN268201800015I
Identifier Type: -
Identifier Source: org_study_id