Cancer, Cardiovascular Diseases, Chronic Disease, Diabetes Mellitus, Lifestyle-related Condition, Mental Health Wellness 1, Nutritional and Metabolic Disease, Nutritional Imbalance, Nutrition Related Cancer, Sleep, Thyroid
Conditions
Brief summary
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
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.
Interventions
OTHERNutritarian 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.
Sponsors
Northern Arizona University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Hybrid effectiveness-implementation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition Intervention | Every 12 months, up to 10 years. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Measurement | Every 12 months, up to 10 years. | Self-measured and reported measurements in inches. |
| Hip Measurement | Every 12 months, up to 10 years. | Self-measured and reported measurements in inches. |
| Mental Health | Every 12 months, up to 10 years. | 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). |
| Weight Management | Every 12 months, up to 10 years. | Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m\^2. |
| Cancer prevalence | Every 12 months, up to 10 years. | Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population. |
| Chronic disease prevalence | Every 12 months, up to 10 years. | Self-reported occurrence, recurrence, and progression of chronic disease (diabetes, cardiovascular disease, inflammatory disease). Will be expressed as frequency distribution across the study population. |
| Sleep quality assessment | Every 12 months, up to 10 years. | 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. |
Countries
United States
Outcome results
None listed