Cardiovascular DiseasesNCT06286618
Nutrition360: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
A study testing Psychosocial Intervention, Structural Intervention and Traditional Psychosocial+Structural in people with Cardiovascular Diseases, run by University of Southern Mississippi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Psychosocial Intervention, Structural Intervention and Traditional Psychosocial+Structural
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 24 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
The University of Southern Mississippi
Hattiesburg, Mississippi, 39406-0001
About this study
Official title: Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Psychosocial Intervention, Structural Intervention, Traditional Psychosocial+Structural, Integrated Psychosocial+Structural
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial InterventionBehavioural
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 InterventionOther
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+StructuralOther
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+StructuralOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Psychosocial+Structural; Other: Integrated Psychosocial+Structural |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 weeks
Secondary outcomes (3)
cost effectiveness
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.
Measured: 3 months
session attendance
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.
Measured: 3 months
diet quality
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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Sep 2022
- Primary completion24 Sep 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Mississippi
- Sponsor type
- University, hospital or other
- Collaborators
- My Brother's Keeper, Inc.
- Responsible party
- Sponsor
- Investigators
- June Gipson, PhD, Principal investigator, My Brother's Keeper, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286618
- Sponsor's protocol ID
- HHSN268201800015I
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is pilot in nature and is being used to support intervention development. Due to the small sample size, the data would not be suitable for secondary analysis.
Publications
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.
PubMed 39236781
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moving to Integrated and Holistic Disease Prevention Among Underserved Mississippians
- ClinicalTrials.gov ID
- NCT06286618
- Acronym / sponsor ID
- HHSN268201800015I
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Southern MississippiUniversity, hospital or other
- Collaborators
- My Brother's Keeper, Inc.
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosocial or Structural Intervention | Experimental | Behavioral: Psychosocial Intervention, Other: Structural InterventionDuring 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 | Experimental | Other: Traditional Psychosocial+Structural, Other: Integrated Psychosocial+StructuralThe 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial InterventionPsychosocial 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. | Behavioural | Psychosocial or Structural Intervention |
| Structural InterventionThe 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. | Other | Psychosocial or Structural Intervention |
| Traditional Psychosocial+StructuralParticipants 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. | Other | Combined Psychosocial and Structural Intervention |
| Integrated Psychosocial+StructuralParticipants 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. | Other | Combined Psychosocial and Structural Intervention |
Primary outcome
Participant Burden
Time frame: 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.
3 secondary outcomes
cost effectiveness
Time frame: 3 months
session attendance
Time frame: 3 months
diet quality
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 39236781Lemacks 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.
- Individual participant dataSharing planned: No. The study is pilot in nature and is being used to support intervention development. Due to the small sample size, the data would not be suitable for secondary analysis.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
June Gipson, PhD principal investigator
My Brother's Keeper, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Intervention, Structural Intervention and Traditional Psychosocial+Structural in people with Cardiovascular Diseases, run by University of Southern Mississippi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Burden (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.