written materials plus asked to form implementation intentions

written materials only

written materials

telephone support

Zora Djuric, PhD

The main aim of this study is to determine if persons can increase fruit and vegetable intakes if they make a specific plan to do so.

The conduct of cancer prevention trials through community settings and/or national networks of clinical sites requires the development of appropriate interventions. One promising behavioral strategy that is very simple to administer is that of the formulation of implementation intentions. The premise of this intervention is that once persons formulate a plan of action, automatic behavior follows. Use of this intervention in primary care is an innovative approach to eliciting preventive behaviors with minimal staff time. The goal in this study will be to increase fruit and vegetable consumption by 2 servings/day without a change in overall energy intakes by decreasing consumption of a less nutritious food. Substitution of foods is critical for prevention of weight gain. This feasibility study aims conduct a randomized, controlled clinical trial to test whether formulation of implementation intentions, either alone or with telephone support, can increase fruit and vegetable consumption without an increase in overall energy intakes. Recruitment success in a family medicine clinic in Ypsilanti Michigan will be documented with emphasis on the extent of minority participation. Dietary assessment will be the main outcome variable. Other assessments will include demographics, self-assessment of behaviors targeted by the intervention and levels of carotenoids in plasma. We will enroll 105 subjects to retain 28/arm, and power is good to detect small differences in fruit and vegetable intakes among the three study arms. This will generate useful data for the design of larger dietary intervention trials that are cost-effective and which will utilize multiple clinical sites to optimize enrollment.

The Fruit and Vegetable Study

Implementation Intentions for Improving Fruit and Vegetable Intakes

University of Michigan

Research Professor

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Body Weight

The control arm receives written information and pedometers

This arm also receives telephone counseling.

motivational interviewing

dietary guidance materials and pedometers

This study aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond.

Women receiving chemotherapy for early stage breast cancer often gain weight and body fat, and this contributes to the health burden that cancer survivors face. Weight gain is a concern not only for overall health status, but also as a possible factor for risk of cancer recurrence. Unfortunately achieving weight loss, after a gain has occurred, is difficult, and there are no satisfactory methods for maintenance of weight loss. This study proposes to design and test a novel telephone-based intervention for preventing weight gain during treatment for breast cancer in a pilot, randomized study. The 12-month intervention will target maintenance of current weight and prevention of body fat gain using counseling for moderate exercise and a low-fat, high fruit-vegetable diet. The counseling approach will be based on motivational interviewing techniques and will be delivered through telephone appointments. Motivational interviewing is a client-centered type of counseling that elicits active participation of the patient. By taking a more active role, patients may be more likely to follow through with the recommended lifestyle changes. Study endpoints will include blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires (including quality of life) and anthropometric measures (including body fat by DEXA). An important goal of the study is to establish recruitment methods and demonstrate recruitment rates in newly diagnosed stage I-IIIA breast cancer patients. The study data also will demonstrate implementation of the counseling approach and provide a basis for sample size estimates for a larger trial. This type of intervention, namely a combination of exercise and diet, has been indicated to have good potential for prevention of recurrence. It is therefore necessary to develop effective methods for eliciting these behaviors.

The Women's Healthy Lifestyle Study

Motivational Interviewing for Weight Maintenance

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

All Drugs and Chemicals

Herbal and Botanical

Chlorophyllin

Protective Agents

Cola

Participants will complete the 4 week intervention, 4 week washout, then 4 week control period (monitor only)

Participants will complete the 4 week control period (monitor only), 4 week washout, then 4 week intervention

Participants will be provided frozen dark leafy green vegetables, and counseled to consume 1 cup cooked dark green leafy vegetables (2 servings) daily over the 4 week period while maintaining their normal red meat intake. This will occur during the first 4 week period of the study.

High chlorophyll diet - intervention 1st

Participants will be provided frozen dark leafy green vegetables, and counseled to consume 1 cup cooked dark green leafy vegetables (2 servings) daily over the 4 week period while maintaining their normal red meat intake. This will occur during the last 4 week period of the study.

High chlorophyll diet - control 1st

Andrew D Fruge, PhD, RD

Colon cancer is the third most common cancer in men and women and over 70% of cases are preventable. A western diet, characterized by low vegetable and high red and processed meat intake, indisputably increases colon cancer risk. Heme, which gives red meat its color, is highly reactive, induces hyperproliferation and promotes DNA damage in the colon to a greater degree than any other red meat-associated carcinogen. Preclinical models indicate dietary chlorophyll, which gives green leafy vegetables their color, binds and stabilizes heme in the lumen, preventing genotoxicity. Additionally, data from our randomized controlled weight loss trial indicate increasing red meat consumption has deleterious effects on the gut microbiome, which is also implicated in colon cancer etiology. Because heme-containing foods are the richest sources of bioavailable iron and several other vitamins and minerals, mitigating their potential risks may be more beneficial than eliminating meat, poultry, fish and seafood in their entirety from the diet for risk reduction.

This feasibility study will begin to explore the research question: Will adding chlorophyll-rich green leafy vegetables to the diet prevent the deleterious effects of heme-rich red meat on the human host and microbiome? The investigators will randomly assign 50 adults at increased risk of colorectal adenoma to a block randomized crossover study with two 4-week dietary regimens in which: 1) participants will be provided with frozen green leafy vegetables and counseled to consume a high chlorophyll diet including 1 cup per day of cooked green leafy vegetables and normal meat (high heme) consumption; or 2) continue their normal high heme, low chlorophyll diet (control). A 4-week washout period encouraging habitual diet will be employed between the intervention periods and data will be collected at all four time points.

This study is critical in translating preclinical findings and has the potential to open the door to new knowledge and standards of care in colon cancer prevention. This study is a required step to aid in the design of a larger RCT to determine whether increased green leafy vegetable consumption mitigates the negative effects of red meat on DNA damage, inflammatory cytokines and gut microbe composition. This could lead to equally beneficial dietary guidance for colon health that might be more easily attained by the general public through addition, rather than omission of specific foods.

Fifty thousand cases of colon and rectal cancer (CRC) could be prevented each year through screening, increased exercise and improved diet. Obesity alone increases risk of CRC by 33% and is associated with increased CRC mortality. Red and processed meat consumption is associated with increased CRC risk, most often in the context of dietary patterns, which juxtapose "Western" and "prudent" diets. A recent meta-analysis of 24 case control studies and 11 prospective cohort studies (n=1,295,063 men and women) found an 18% reduction in risk for colon cancer in the groups consuming the highest levels of cruciferous and green leafy vegetables. Risk reduction with high green leafy vegetable consumption remained significant regardless of whether pooled studies controlled for meat and/or total energy intake.

Heme-induced genotoxicity of the colon is prevented by chlorophyll in rodent models; an important finding that has not been tested in clinical trials though is supported by epidemiological observation.

This trial utilizes a crossover design to assess the feasibility of a dietary intervention in adults at increased risk of CRC. The overall intent of this line of research is to elucidate a CRC risk-reducing dietary pattern that is accessible to the general public. Therefore, obese, meat-eating participants will be randomized to an intervention and control diet: 1) high chlorophyll (green leafy vegetables) and high heme (normal meat) consumption; and 2) habitual high heme, low chlorophyll diet (control). During the intervention periods, all participants will receive individual dietary counseling from a registered dietitian two days per week to reinforce daily consumption goals based on the amounts of chlorophyll and heme in various foods. This study translates preclinical models, utilizes an appropriate at-risk population, and if feasible, has the potential to be tested for efficacy for the reduction of colon cancer risk.

Participants will be recruited through the Auburn University Pharmaceutical Care Clinic and throughout the Auburn community. After completing all baseline procedures, participants will be block randomized by gender due to potential differences in fecal microbiome. All participants will receive the intervention; the order in which it is received will be randomly generated. For the high chlorophyll study arm, a goal of 1 cup cooked dark leafy green vegetables will be prescribed, and participants will be instructed to consume at least ½ cup cooked dark green leafy vegetables during the same meal they consume red meat. The high chlorophyll group will also receive a variety of frozen dark green leafy vegetables, including, spinach, kale, collards, mustard greens, and turnip greens. Frozen vegetables are provided because flash-freezing minimizes nutrient loss and prevents chlorophyll degradation. Though the chlorophyll content varies between these species, it is exponentially higher than other green vegetables in the brassica family. Participants will be instructed to consume cooked vegetables, rather than raw, to increase the bioavailability of chlorophyll and reduce the volume of the needed amount of vegetable.

After each 4-week period, participants will complete questionnaires, return unused frozen vegetables (which will be tracked), provide a stool sample, and undergo phlebotomy. Study staff will obtain two 24-hour dietary recalls on non-consecutive days. Participants will be provided with an additional fecal collection kit for the sample that will be obtained prior to the next dietary arm assignment.

The behavioral framework of this intervention will utilize Social Cognitive Theory as the basis for behavior change in each intervention arm. Participants will increase self-efficacy of dietary adherence by setting goals and logging daily food intake (self-monitoring), which will be assessed in twice weekly counseling sessions with a registered dietitian.

4 week intervention and control periods will be delivered and separated by a 4 week washout. The order of intervention and control periods will be randomly allocated

Exploring the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults

Exploring the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults: The Meat and Three Greens Feasibility Trial

Retain 90% of sample at crossover and 80% at completion

Meet chlorophyll intake goals 90% of days

16s changes in microbiota alpha diversity

Body fat percentage using Bioelectrical Impedence Analysis

Acceptability of the diets will be measured by the Food Acceptability Questionnaire (FAQ) total score. The FAQ is a 10 item questionnaire scored on a 7-point likert scale with total scores ranging from 7-70.

Auburn University

Assistant Professor and Director, Didactic Program in Dietetics

Participants receive 3 phone calls from a peer counselor to deliver counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 6 week period.

peer counseling

Participants receive a one-page printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.

Feedback report

Lisa M Quinitiliani, PhD, RD

The purpose of this research study is to evaluate the effectiveness of two methods of delivering information about nutrition and physical activity to non-traditional college students. Participants will receive either a printed feedback report alone, or the feedback report in addition to a series of phone calls from a peer counselor. The peer counselors will provide nutrition and physical activity counseling using motivational interviewing techniques. Nutrition and physical activity outcomes will be measured for both groups and compared.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Fruit and Vegetable Study	NCT00468156	Cancer	written materia... written materia... telephone suppo...	40 Years -	University of Michigan
The Women's Healthy Lifestyle Study	NCT00583726	Breast Cancer	motivational in... written materia...	18 Years - 99 Years	University of Michigan
Exploring the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults	NCT03582306	Colon Cancer Pr...	High chlorophyl... High chlorophyl...	18 Years -	Auburn University
Exploring the Effects of a High Chlorophyll Dietary Intervention to Reduce Colon Cancer Risk in Adults	NCT03582306	Colon Cancer Pr...	High chlorophyl... High chlorophyl...	18 Years -	Auburn University
Nutrition and Physical Activity Counseling for Nontraditional College Students	NCT01412099	Health Behavior	peer counseling Feedback report	18 Years -	Boston Medical Center

Spots Global Cancer Trial Database for vegetables

Every month we try and update this database with for vegetables cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vegetables

Every month we try and update this database with for vegetables cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vegetables cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.