NCT03330548

Brief Summary

The purpose of this study is to conduct a preliminary test of the effectiveness of various educational interventions to promote adoption of a whole-food, plant-strong diet and reduce specific cardiovascular risk factors in Veterans, and subsequently perform a preliminary pilot study on whether this dietary approach will change plaque inflammation and endothelial function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2021

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

5.7 years

First QC Date

October 25, 2017

Last Update Submit

March 9, 2021

Conditions

HyperlipidemiasOverweight and ObesityDiabetes

Keywords

Plant-based dietHyperlipidemiaDiabetesOverweightVeterans

Outcome Measures

Primary Outcomes (1)

  • Change in Low-density lipoprotein (LDL)

    Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)

    90 days, 6 months and one year from baseline

Secondary Outcomes (6)

  • Change in Dietary pattern

    90 days, 6 months and one year from baseline

  • Change in carotid plaque

    90 days from baseline

  • Change in aortic pulse wave velocity

    90 days from baseline

  • Change in Total Cholesterol

    90 days, 6 months and one year from baseline

  • Change in Weight

    90 days, 6 months and one year from baseline

  • +1 more secondary outcomes

Study Arms (2)

TeleMOVE!

ACTIVE COMPARATOR

Veterans randomized to the control arm will participate in TeleMOVE!, an arm of the Management of Overweight Veterans (MOVE!) program. TeleMOVE! is telehealth treatment program within the VA designed to improve the lives of Veterans by assisting with weight management and health promotion. This program includes daily interaction with in-home messaging technologies and clinician contact as needed

Behavioral: TeleMOVE!

Culinary Rx

EXPERIMENTAL

Veterans randomized to the experimental arm will participate in Culinary Rx. Culinary Rx is an online instructional cooking and nutrition course that healthcare professionals can prescribe to patients who need to transition away from a Standard American Diet to a more health-supportive, whole foods, plant-based lifestyle. In partnership with The Plantrician Project, this course will focus on teaching the foundational cooking skills needed for long-term behavioral change, coupled with lifestyle education around nutrition and resources that will help users successfully face the many challenges inherent to dietary change.

Behavioral: Culinary Rx

Interventions

TeleMOVE!BEHAVIORAL

Active comparator- telehealth treatment program for weight management and health promotion

TeleMOVE!
Culinary RxBEHAVIORAL

Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.

Culinary Rx

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 and \< 90
  • BMI \>25 and \< 40
  • Subject has hypertension, diabetes, hyperlipidemia, or overweight/obesity based upon recognized body mass index (BMI) standards) and an interest and desire to make a lifestyle change.Ability to tolerate two FDG-PET-MRI scans.
  • Active telephone contact information (either land line or cell phone)
  • No contraindication to be on a PSD.
  • Access to transportation and a functioning kitchen
  • The ability to prepare meals independently.
  • Access to a computer or tablet with internet access
  • Digital camera or Smartphone
  • Pooled risk cohort score ≥ 7.5%.
  • No contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes).

You may not qualify if:

  • \. Significant unplanned weight loss within the last six months 2. BMI \< 25 or \> 40 3. Uncontrolled insulin-dependent diabetes with a current HbA1C of over 9% 4. Contraindication to undertake a PSD 5. Age \<18 years old 6. Pregnancy/lactation 7. Taking prescribed weight loss medication(s) 8. Currently following a plant-strong diet, vegan, or medical weight loss program diet 9. Celiac disease diagnosed within the last six months 10. End-stage hepatic disease or renal disease requiring dialysis 11. Active cancer or receiving chemotherapy or radiation therapy 12. Active alcohol or substance abuse problems 13. History of eating disorders 14. Fasting triglyceride level above 350 mg/dL 15. Any psychological issues that prevent compliance 16. Unable to speak the English language 17. Have limited mobility 18. Homeless or in housing with limited kitchen access
  • Inability to tolerate PET scans.
  • Contraindication to magnetic resonance imaging (moderate or severe claustrophobia, ferromagnetic materials, inability to lie flat for 30 minutes)
  • Women of childbearing potential who do not have medical documentation of surgically induced menopause.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix VA Health Care System

Phoenix, Arizona, 85012, United States

Location

MeSH Terms

Conditions

HyperlipidemiasOverweightObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Diane J Parrington, PhD

    Phoenix VA Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor for the imaging studies will be blinded to the study arms of the subjects.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects will be randomized 2:1 into Culinary Rx or TeleMOVE! prior to baseline measures. We plan to enroll a subset of the 80 participants to undergo a PET-MRI sub-study (total of 21 participants). This cohort requires participants to have a pooled cohort risk score of ≥ 7.5%, be willing and able to undergo FDG-PET-MRI. \[The ACC/AHA pooled risk calculator utilizes information such as age, lipid profile, hypertension to estimate 10 year risk of ASCVD.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Associate Chief of Staff for Research

Study Record Dates

First Submitted

October 25, 2017

First Posted

November 6, 2017

Study Start

July 9, 2015

Primary Completion

March 5, 2021

Study Completion

March 5, 2021

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

The study start date was before January 18, 2017, so no plan is in place.

Locations

US(1)