An interventional study of TeleMOVE! and Culinary Rx in Hyperlipidemias, Overweight and Obesity and Diabetes, sponsored by Phoenix VA Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Phoenix VA Health Care System · Not applicable, Interventional, and Treatment
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.
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. The specific aims are to conduct a preliminary examination of:
The feasibility of Veterans to adopt a whole-food, plant-strong diet within five weeks, following a plant-strong protocol, or within 90 days following a Plant Strong Diet (PSD) using Culinary Rx, or by TeleMOVE! (standard of care control). Feasibility factors will evaluate acceptability and practicality by a measure of the recruitment process, attrition rate, reasons for dropping, perceived benefit, and comparison of dietary pattern changes before and after the intervention.
a. Acceptability of a plant-strong diet.
(Part 1) The effectiveness of a five-week whole-food, plant-strong diet on participants':
(Part 3) The effectiveness of completing Culinary Rx as compared to TeleMOVE! for 90 days on participants':
Establish the ability of Positron Emission Tomography 18F-fluorodeoxyglucose radiopharmaceutical and magnetic resonance imaging (PET FDG-MRI) to assess serial change in plaque inflammation and plaque volume (Part 2) and then perform a pilot test to assess whether a 90-day PSD using Culinary Rx, or TeleMOVE! reduces plaque inflammation using FDG uptake on PET scan and structural changes on MRI (Part 3).
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's enrollment of 87 is close to the median of 88 across 735 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Phoenix VA Health Care System is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria: U.S. Veterans only
For the FDG-PET-MRI subset/portion of the study, there are additional inclusion criteria:
Inclusion criteria:
Exclusion Criteria:
For the FDG-PET-MRI subset/portion of the study, there are additional exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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!
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
Active comparator- telehealth treatment program for weight management and health promotion
Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.
Change in Low-density lipoprotein (LDL)
Fasting Low-density lipoprotein measured in milligrams per deciliter (mg/dl)
Time frame: 90 days, 6 months and one year from baseline
Change in Dietary pattern
Degree to which meat, fish, dairy and added oils are decreased or eliminated from the dietary pattern; as well as the degree to which the consumption of fruits and vegetables (particularly whole-foods) are increased from baseline intake.
Time frame: 90 days, 6 months and one year from baseline
Change in carotid plaque
Plaque volume
Time frame: 90 days from baseline
Change in aortic pulse wave velocity
aortic pulse wave velocity
Time frame: 90 days from baseline
Change in Total Cholesterol
Fasting total cholesterol measured in milligrams per deciliter (mg/dl)
Time frame: 90 days, 6 months and one year from baseline
Change in Weight
Weight in kilograms measured with subject in light clothing without shoes
Time frame: 90 days, 6 months and one year from baseline
Change in Hemoglobin A1C (HgbA1c)
Hemoglobin A1c measured as %
Time frame: 90 days, 6 months and one year from baseline
Plan to share: No — The study start date was before January 18, 2017, so no plan is in place.
No publications or documents are linked to this record.
Ran from Jul 2015 to primary completion in Mar 2021, 67 months.
Of 166 non-industry interventional studies with no phase under Hyperlipidemias, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 67 months is above that.
Counting every sponsor, half of 171 studies reached it within 15 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Phoenix VA Health Care System