Gland and Hormone Related Diseases

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Rare Diseases

Thyroid Diseases

Diabetes Mellitus

Metabolic Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

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

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.

Nutritarian Diet-style

Jay Sutliffe

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).

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.

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

Nutritarian Women's Health Study to Reduce Chronic Disease

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

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).

Height/weight/BMI of participants through self-reported measurements. Weight and height will be combined to report BMI in kg/m\^2.

Self-measured and reported measurements in inches.

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).

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.

Self-reported occurrence, recurrence, and progression of cancer at any site. Will be expressed as frequency distribution across the study population.

Self-reported occurrence, recurrence, and progression of chronic disease (diabetes, cardiovascular disease, inflammatory disease). Will be expressed as frequency distribution across the study population.

Northern Arizona University

Associate Professor

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Recurrence

Lung Neoplasms

Malnutrition

Carcinoma

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Small Cell Lung Cancer

The oncology care team will provide participants with nutrition toolkit involving printed educational materials, a nutrition prescription, referral to registered dietitians (RDs) for remotely-delivered medical nutrition therapy counseling, and home-delivery of medically tailored meals.

The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.

Medical oncology providers will refer participants to oncology RDs for remotely delivered medical nutrition therapy counseling. For cohort 1, participants will receive nutrition counseling for 8 months. The counseling will be provided on a weekly basis during the first 6 months and every other week during the last 2 months (for cohort 1 only). For cohort 2, participants will receive nutrition counseling for 6 months. The ultimate frequency of nutrition counseling being provided to each participant will also be adjusted according to the participant's preference and needs.

Nutritional Counseling

Medically tailored meals will be provided to participants in the intervention group for a total of 24 weeks for both cohorts. During the first 8 weeks of the intervention, 3 meals/day will be provided each week for a total of 168 meals per participant. It will be followed by less frequent meal provision during the subsequent 16 weeks following this schedule: 3 meals/day will be provided every other week for the next 8 weeks (a total of 84 meals per participant); and 3 meals/day will be provided every four weeks during the last 8 weeks (a total of 42 meals per participant). The number of meals provided to each participant may be adjusted according to participant's preference and needs.

Medically Tailored Meals (MTMs)

Oncology providers will advise participants with lung cancer to follow evidence-based nutrition recommendations using a Nutrition Prescription. The Nutrition Prescription aims to enhance providers' role in communicating basic nutrition advice to participants with lung cancer. It contains seven recommendations, adapted from the newly released Cancer Prevention Recommendations by WCRF/AICR with strong evidence-base.

Nutrition Prescription

Oncology care providers will assess the nutritional status of patients with lung cancer using PG-SGA Short Form (the Scored Patient-Generated Subjective Global Assessment). PG-SGA is an interdisciplinary patient assessment in oncology and other chronic catabolic conditions. The short form contains four patient generated historical components (weight history, food intake symptoms, and activities and function).

Nutrition Assessment

Patients will receive a printed copy of a Nutrition Toolkit from providers. Evidence-based nutrition recommendations have been compiled for cancer survivors from 4 sources into a Nutrition Toolkit. The sources include: (1) AmericanCancer Society (ACS) Nutrition and Physical Activity Guidelines for Cancer Survivors; (2)World Cancer Research Fund / American Institute for Cancer Research (WFRF/AICR) Cancer Nutrition Guide; (3) National Cancer Institute (NCI) Eating Hints; and (4) National Comprehensive Cancer Network (NCCN) Guidelines for Cancer Survivors. The Nutrition Toolkit outlines topics about the impact of cancer treatment on dietary intake patterns and quality, strategies to manage treatment-related eating issues, maintaining a healthy weight post treatment, and evidence-based recommendations and practical. Nutrition Toolkit strategies for improving diet quality and maintaining an optimal weight for cancer survivors.

Nutrition Toolkit

Monthly emails will be sent to participants to encourage the use of the toolkit with healthy recipes and general nutrition information.

Monthly Emails

FangFang Zhang, MD, PhD

Colleen Spees, PhD, MEd, RD, LD, FAND

The NutriCare study aims to develop, implement, and evaluate the efficacy of an innovative intervention strategy (medically tailored meals plus nutrition counseling) to integrate nutrition into the standard of care for oncology to improve outcomes of vulnerable patients with lung cancer. The NutriCare study evaluates the efficacy of the intervention on optimizing nutritional status, reducing treatment-related toxicities, and improving the quality of life of patients with lung cancer who are economically disadvantaged, uninsured, racial and ethnic minorities, elderly, and/or rural residents from four major medical centers in diverse regions of the United States (U.S.). There will be two cohorts for NutriCare with cohort 1 recruiting 150 patients completing an 8-month intervention and cohort 2 recruiting 120 patients completing a 6-month intervention.

For the proposed study, we will randomize participants into two groups at a 1:1 ratio to an intervention or an enhanced control group. For participants randomized to the enhanced control group, the NutriTool, the oncology care team will provide participants with a nutrition toolkit involving printed educational materials. For participants randomized to the intervention group, the NutriCare, the oncology care team will additionally provide participants with home-delivery of medically tailored meals and referral to registered dietitians (RDs) for remotely-delivered nutrition counseling.

NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer

NutriCare Intervention on Optimizing Nutritional Status, Reducing Treatment-Related Toxicities, and Improving Quality of Life Among Vulnerable Patients With Lung Cancer

(a) participation; (b) retention; (c) compliance

Change in diet quality and intake of key food groups and nutrients as assessed by the National Cancer Institute Diet History Questionnaire (DHQ III)

Change in weight and percent weight loss as measured in the clinic

Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey

Change in patient-reported symptoms (fatigue, pain, nausea, vomiting, appetite loss, and sleep disturbance) as assessed by a Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE)

Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by GAD-7

Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by PHQ-9

Change in quality of life as assessed by EORTC-QLQ-30

Change in quality of life as assessed by EORTC-QLQ-LC13

Rate of hospitalizations will assessed by medical record review and linkage with discharge data

Rate of ED visits assessed by medical record review and linkage with discharge data

Rate of treatment-related toxicities assessed by the treating medical oncologist using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)

Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist

Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)

National Death Index search performed approximately 5 years after the final patient is enrolled.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Nutritarian Study to Evaluate the Effectiveness of Lifestyle Changes in Chronic Disease Prevention, Especially Cancer	NCT03430141	Chronic Disease Cancer Cardiovascular ... Diabetes Mellit... Lifestyle-relat... Mental Health W... Sleep Nutritional and... Nutrition Relat... Nutritional Imb... Thyroid	Nutritarian Die...	18 Years -	Northern Arizona University
NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer	NCT04986670	Lung Cancer, Sm... Lung Cancer Met... Lung Cancer Rec... Treatment Side ... Lung Cancer, No... Nutritional Imb...	Nutritional Cou... Medically Tailo... Nutrition Presc... Nutrition Asses... Nutrition Toolk... Monthly Emails	18 Years - 100 Years	Tufts University

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