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NCT Number: NCT03430141

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

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).

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Key information

Conditions

Chronic Disease Cancer Cardiovascular Diseases Diabetes Mellitus Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Lifestyle-related Condition Mental Disorders Mental Health Wellness 1 Metabolic Diseases Neoplasms Nutrition Related Cancer Nutritional Imbalance Nutritional and Metabolic Disease Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Thyroid Thyroid Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northern Arizona University

Flagstaff, Arizona, 86011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritarian Diet-style

Other

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 outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. Waist Measurement

    Time frame: Every 12 months, up to 10 years.

    Self-measured and reported measurements in inches.

  3. Hip Measurement

    Time frame: Every 12 months, up to 10 years.

    Self-measured and reported measurements in inches.

  4. 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).

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Northern Arizona University

Other

Registry information

Official study title

Nutritarian Women's Health Study to Reduce Chronic Disease

Acronym: NWHS

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2018
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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