Cancer Clinical Trial
— NWHSOfficial title:
Nutritarian Women's Health Study to Reduce Chronic Disease
Verified date | September 2020 |
Source | Northern Arizona University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 2898 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Northern Arizona University | Flagstaff | Arizona |
Lead Sponsor | Collaborator |
---|---|
Northern Arizona University |
United States,
Fuhrman J, Sarter B, Glaser D, Acocella S. Changing perceptions of hunger on a high nutrient density diet. Nutr J. 2010 Nov 7;9:51. doi: 10.1186/1475-2891-9-51. — View Citation
Gonzales JF, Barnard ND, Jenkins DJ, Lanou AJ, Davis B, Saxe G, Levin S. Applying the precautionary principle to nutrition and cancer. J Am Coll Nutr. 2014;33(3):239-46. doi: 10.1080/07315724.2013.866527. Epub 2014 May 28. Review. — View Citation
Jenkins DJ, Kendall CW, Faulkner DA, Nguyen T, Kemp T, Marchie A, Wong JM, de Souza R, Emam A, Vidgen E, Trautwein EA, Lapsley KG, Holmes C, Josse RG, Leiter LA, Connelly PW, Singer W. Assessment of the longer-term effects of a dietary portfolio of choles — View Citation
Sarter B. Effect of a high nutrient density diet on long-term weight loss: a retrospective chart review. Altern Ther Health Med. 2011 Nov-Dec;17(6):10; author reply 10. — View Citation
Sutliffe JT, Fuhrman JH, Carnot MJ, Beetham RM, Peddy MS. Nutrient-dense, Plant-rich Dietary Intervention Effective at Reducing Cardiovascular Disease Risk Factors for Worksites: A Pilot Study. Altern Ther Health Med. 2016 Sep;22(5):32-6. — View Citation
Sutliffe JT, Wilson LD, de Heer HD, Foster RL, Carnot MJ. C-reactive protein response to a vegan lifestyle intervention. Complement Ther Med. 2015 Feb;23(1):32-7. doi: 10.1016/j.ctim.2014.11.001. Epub 2014 Dec 3. — View Citation
Tucker KL, Hallfrisch J, Qiao N, Muller D, Andres R, Fleg JL; Baltimore Longitudinal Study of Aging. The combination of high fruit and vegetable and low saturated fat intakes is more protective against mortality in aging men than is either alone: the Balt — View Citation
Yokoyama Y, Barnard ND, Levin SM, Watanabe M. Vegetarian diets and glycemic control in diabetes: a systematic review and meta-analysis. Cardiovasc Diagn Ther. 2014 Oct;4(5):373-82. doi: 10.3978/j.issn.2223-3652.2014.10.04. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | Waist Measurement | Self-measured and reported measurements in inches. | Every 12 months, up to 10 years. | |
Secondary | Hip Measurement | Self-measured and reported measurements in inches. | Every 12 months, up to 10 years. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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