A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Nutritarian Women's Health Study to Reduce Chronic Disease

Conditions
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Chronic Disease, Cancer, Cardiovascular Diseases, Diabetes Mellitus, Lifestyle-related Condition, Mental Health Wellness 1, Sleep, Nutritional and Metabolic Disease, Nutrition Related Cancer, Nutritional Imbalance, Thyroid

Intervention / Treatment
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* Other: Nutritarian Diet-style


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Women only Age 18 years and older. Must be willing to complete an online program Follow the dietary guidelines as outlined to the best of their ability. English-speaking US residents Have internet access Pregnant women are eligible Exclusion criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Hybrid effectiveness-implementation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention for all participants<br>Nutritarian Diet-style: Intervention for all participants: All participants are exposed to the same nutrition treatment/intervention protocol. | Other: Nutritarian Diet-style<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Every 12 months, up to 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Management | Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m^2. | Every 12 months, up to 10 years. | 
| Waist Measurement | Self-measured and reported measurements in inches. | Every 12 months, up to 10 years. | 
| Hip Measurement | Self-measured and reported measurements in inches. | 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). | 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. | 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. | 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. | Every 12 months, up to 10 years. |