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

Nutritional and Metabolic Diseases

Obesity

Overweight

Overnutrition

Nutrition Disorders

This group will set goals and form action intentions (plans) to facilitate goal attainment.

This group will set goals and form coping intentions (plans) to facilitate goal attainment.

This group will set goals, form action intentions (plans), and form coping intentions (plans) to facilitate goal attainment.

simple goal setting

This group will set goals and form action intentions (plans)

goal setting plus action intentions

This group will set goals and form coping intentions (plans)

goal setting plus coping intentions

This group will set goals and form action intentions and coping intentions

goal setting plus action intentions plus coping intentions

The primary purpose of this research is to test the effects of goal setting on fruit and vegetable goal attainment and consumption in a 10 episode video game. Factors associated with maintenance of behavior change will also be examined. Secondary purposes are to explore the impact of the intervention on psychosocial factors and the home environment. 400 parent-child pairs will be recruited for this research (800 participants total). Children will play the video game and participate in data collection activities. Parents will receive newsletters, have access to a healthy foods web site, and participate in data collection activities. A small subset will be randomly selected to participate in interviews about the intervention and its effect on the home food environment.

Obesity is increasing among youth and is associated with increased risk of certain cancers and other chronic diseases. Fruit, juice, and vegetable (FJV) intake is associated with decreased risk of many types of cancer and obesity, but is well below the recommended minimum of five servings a day. Innovative methods are needed to promote increased consumption among youth.

Goal setting enhances goal attainment and, therefore, facilitates behavior change. Little research has been conducted, however, on the most effective goal setting methods to use with youth. Among adults, the formation of implementation intentions (a detailed plan of when, where, and how goals will be achieved) has been shown to enhance goal attainment and/or behavior change, including dietary change. Research is needed to determine if extending the goal setting process to include implementation intentions is an effective method for enhancing goal attainment, and therefore, increasing FJV intake among youth.

Squire's Quest! is a proven-effective 10-session, 5 week interactive multi media program that enabled children to increase FJV consumption by 1.0 servings a day. Total consumption was still well below five servings a day, however. Additionally, goal attainment was related to FJV consumption among certain sub-groups of youth. Therefore, additional work in this area is warranted. The research outlined in this proposal will expand the goal setting component of this successful intervention to include the formation of implementation intentions. Hypotheses related to the impact of implementation intentions on goal attainment and FJV consumption will then be tested. Issues related to maintenance of youth dietary behavior change will also be explored.

This project is relevant to public health because enhancing our understanding of how to more effectively help young children set and achieve FJV goals should result in increased FJV consumption, which should decrease risk of both obesity and certain cancers in a vulnerable segment of the population.

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
Squire's Quest! II: Implementation Intentions and Children's Fruit, Juice, and Vegetable (FJV) Consumption	NCT01004094	Obesity Cancer	simple goal set... goal setting pl... goal setting pl... goal setting pl...	8 Years - 12 Years	Baylor College of Medicine

Spots Global Cancer Trial Database for fruit

Every month we try and update this database with for fruit 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 fruit

Every month we try and update this database with for fruit 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 fruit 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.