An interventional study of Nutritarian Diet-style in Chronic Disease, Cancer and Cardiovascular Diseases, sponsored by Northern Arizona University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-22.
Sponsored by Northern Arizona University · Not applicable, Interventional, and Prevention
The Nutritarian Women's Health Study (NWHS) is a long-term hybrid effectiveness-implementation study on the effect of the Nutritarian Diet on the occurrence, recurrence, and progression of chronic diseases (including all forms of cancer and cardiometabolic risk factors).
The Nutritional Research Foundation, in conjunction with Northern Arizona University, is conducting a long-term health study for women ages 18 and older. This study will address the effects of a nutrient dense, plant-rich diet on the long-term risks of cancer and other chronic diseases.
Participants enroll in a 30-day training module which outlines the benefits of a nutrient-dense, plant-rich diet. At the conclusion of those videos and written modules, they take a short quiz to assess their knowledge and they can enroll in the full study.
All participation is online with ongoing modules on nutrition and lifestyle. There is a comprehensive health history and lifestyle index to be completed. Nutrition questionnaires will be administered an average of every 3-6 months; PHQ-9 (Patient Health Questionnaire) \& PSQI (Pittsburgh Sleep Quality Index) questionnaires an average of every 12 months; serum cardiometabolic measures and liquid biopsies an average of every 18 months.
Exclusion criteria:
Nutritarian Diet-style: Intervention for all participants: All participants are exposed to the same nutrition treatment/intervention protocol.
Other: Nutritarian Diet-style
Nutritarian Diet-style: Daily consumption of greens, beans/legumes, a variety of other vegetables, fresh or frozen fruits, nuts, seeds and whole grains. Participants are encouraged to minimize consumption of refined grains, vegetable oils, processed foods, and to limit animal products.
Nutrition Intervention
Adherence to the recommended dietary protocol with the Nutritarian Health Indicator (©Joel Furhman MD). Scored by points (90-100 excellent, 80-89 good, 70-79 average, \<69 poor).
Time frame: Every 12 months, up to 10 years.
Weight Management
Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: Every 12 months, up to 10 years.
Waist Measurement
Self-measured and reported measurements in inches.
Time frame: Every 12 months, up to 10 years.
Hip Measurement
Self-measured and reported measurements in inches.
Time frame: Every 12 months, up to 10 years.
Mental Health
PHQ-9 (Patient Health Questionnaire-9). Tool designed for screening, diagnosing, monitoring and measuring the severity of depression. Scoring: 5-9 (minimal symptoms), 10-14 (minor depression, dysthymia, mild major depression), 15-19 (major depression, moderately severe), and \>20 (major depression, severe).
Time frame: Every 12 months, up to 10 years.
Sleep quality assessment
PSQI (Pittsburgh Sleep Quality Index). Tool designed to evaluate sleep quality over a 1 month interval. Scoring 0-21 points. Any score \>5 indicates sleep impairment, with higher scores designating poorer sleep and greater impact on daily life.
Time frame: Every 12 months, up to 10 years.
Cancer prevalence
Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population.
Time frame: Every 12 months, up to 10 years.
Chronic disease prevalence
Self-reported occurrence, recurrence, and progression of chronic disease (diabetes, cardiovascular disease, inflammatory disease). Will be expressed as frequency distribution across the study population.
Time frame: Every 12 months, up to 10 years.
Plan to share: Yes — We are considering making this data available to other researchers after we have a substantial number of participants enrolled.
Supporting information: Study protocol, Csr
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Northern Arizona University