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

September 18, 2020 updated by: Jay Sutliffe, Northern Arizona University

Nutritarian Women's Health Study to Reduce Chronic Disease

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2898

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86011
        • Northern Arizona University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition Intervention
Time Frame: 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).
Every 12 months, up to 10 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Management
Time Frame: 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.
Every 12 months, up to 10 years.
Waist Measurement
Time Frame: Every 12 months, up to 10 years.
Self-measured and reported measurements in inches.
Every 12 months, up to 10 years.
Hip Measurement
Time Frame: Every 12 months, up to 10 years.
Self-measured and reported measurements in inches.
Every 12 months, up to 10 years.
Mental Health
Time Frame: 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).
Every 12 months, up to 10 years.
Sleep quality assessment
Time Frame: 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.
Every 12 months, up to 10 years.
Cancer prevalence
Time Frame: 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.
Every 12 months, up to 10 years.
Chronic disease prevalence
Time Frame: 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.
Every 12 months, up to 10 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Arizona University

Investigators

  • Principal Investigator: Jay Sutliffe, Northern Arizona University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2016

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

February 5, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 22, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nutritarian Women's Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We are considering making this data available to other researchers after we have a substantial number of participants enrolled.

IPD Sharing Time Frame

Open October 31, 2016. Closed December 31. 2019.

IPD Sharing Access Criteria

please contact study office at nwhs@nau.edu for information

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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