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

Not Applicable

Completed

• Conditions: Nutritional and Metabolic Disease; Nutritional Imbalance; Chronic Disease; Cardiovascular Diseases; Sleep; Thyroid; Mental Health Wellness 1; Cancer; Diabetes Mellitus; Nutrition Related Cancer
• Interventions: Other: Nutritarian Diet-style

• Registration Number: NCT03430141
• Lead Sponsor: Northern Arizona University

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.

Study Timeline

• Study Start: 2016-10-31
• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2898

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention for all participants	Nutritarian Diet-style	Nutritarian Diet-style: Intervention for all participants: All participants are exposed to the same nutrition treatment/intervention protocol.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Hip Measurement	Every 12 months, up to 10 years.	Self-measured and reported measurements in inches.
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.
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.
Waist Measurement	Every 12 months, up to 10 years.	Self-measured and reported measurements in inches.
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.
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).

Trial Locations

Locations (1)

Northern Arizona University; 🇺🇸 Flagstaff, Arizona, United States