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

Primary Purpose

Chronic Disease, Cancer, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nutritarian Diet-style
Sponsored by
Northern Arizona University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Northern Arizona University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention for all participants

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Weight Management
Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m^2.
Waist Measurement
Self-measured and reported measurements in inches.
Hip Measurement
Self-measured and reported measurements in inches.
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).
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.
Cancer prevalence
Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population.
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.

Full Information

First Posted
August 30, 2017
Last Updated
September 18, 2020
Sponsor
Northern Arizona University
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1. Study Identification

Unique Protocol Identification Number
NCT03430141
Brief Title
A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer
Acronym
NWHS
Official Title
Nutritarian Women's Health Study to Reduce Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northern Arizona University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Hybrid effectiveness-implementation
Masking
None (Open Label)
Allocation
N/A
Enrollment
2898 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention for all participants
Arm Type
Experimental
Arm Description
Nutritarian Diet-style: Intervention for all participants: All participants are exposed to the same nutrition treatment/intervention protocol.
Intervention Type
Other
Intervention Name(s)
Nutritarian Diet-style
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutrition Intervention
Description
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).
Time Frame
Every 12 months, up to 10 years.
Secondary Outcome Measure Information:
Title
Weight Management
Description
Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m^2.
Time Frame
Every 12 months, up to 10 years.
Title
Waist Measurement
Description
Self-measured and reported measurements in inches.
Time Frame
Every 12 months, up to 10 years.
Title
Hip Measurement
Description
Self-measured and reported measurements in inches.
Time Frame
Every 12 months, up to 10 years.
Title
Mental Health
Description
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).
Time Frame
Every 12 months, up to 10 years.
Title
Sleep quality assessment
Description
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.
Time Frame
Every 12 months, up to 10 years.
Title
Cancer prevalence
Description
Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population.
Time Frame
Every 12 months, up to 10 years.
Title
Chronic disease prevalence
Description
Self-reported occurrence, recurrence, and progression of chronic disease (diabetes, cardiovascular disease, inflammatory disease). Will be expressed as frequency distribution across the study population.
Time Frame
Every 12 months, up to 10 years.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women 18 years and older
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay Sutliffe
Organizational Affiliation
Northern Arizona University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Arizona University
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
27622958
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.
Results Reference
result
PubMed Identifier
22314713
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.
Results Reference
result
PubMed Identifier
16522904
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.
Results Reference
result
PubMed Identifier
25414824
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.
Results Reference
result
PubMed Identifier
25637150
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.
Results Reference
result
PubMed Identifier
21054899
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.
Results Reference
result
PubMed Identifier
24870117
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.
Results Reference
result
PubMed Identifier
15735093
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.
Results Reference
result

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

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