Clinical trial NCT03430141: A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer
Official title: Nutritarian Women's Health Study to Reduce Chronic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 2898
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Hybrid effectiveness-implementation
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutrition Intervention
timeFrame: Every 12 months, up to 10 years.
Secondary outcomes:
measure: Weight Management
timeFrame: Every 12 months, up to 10 years.
measure: Waist Measurement
timeFrame: Every 12 months, up to 10 years.
measure: Hip Measurement
timeFrame: Every 12 months, up to 10 years.
measure: Mental Health
timeFrame: Every 12 months, up to 10 years.
measure: Sleep quality assessment
timeFrame: Every 12 months, up to 10 years.
measure: Cancer prevalence
timeFrame: Every 12 months, up to 10 years.
measure: Chronic disease prevalence
timeFrame: Every 12 months, up to 10 years.
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
affiliation: Northern Arizona University
name: Jay Sutliffe
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. No abstract available.
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 cholesterol-lowering foods in hypercholesterolemia. Am J Clin Nutr. 2006 Mar;83(3):582-91. doi: 10.1093/ajcn.83.3.582.
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.
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.
citation: 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.
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.
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 Baltimore Longitudinal Study of Aging. J Nutr. 2005 Mar;135(3):556-61. doi: 10.1093/jn/135.3.556.