The Fruit and Vegetable Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Implementation Intentions for Improving Fruit and Vegetable Intakes

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: written materials only
* Behavioral: written materials
* Behavioral: telephone support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 and older Give informed consent In general good health Less than 5.5 servings/day of fruits and vegetables Exclusion Criteria: On medically prescribed diets that the study would not be consistent with Evidence of eating disorders Health problems that affect energy needs (eg. broken leg can interfere with normal activities and affect energy needs).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>written materials only | Behavioral: written materials only<br>* related to fruit/vegetable servings/day<br>* Other names: control;|
| Experimental: 2<br>written materials plus asked to form implementation intentions | Behavioral: written materials<br>* related to fruit/vegetable servings/day<br>* Other names: asked to form implementation intentions;|
| Experimental: 3<br>same as arm 2 plus telephone support | Behavioral: telephone support<br>* related to fruit/vegetable servings/day<br>* Other names: written plus telephone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document enrollment success at a primary care clinic |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine change in fruit and vegetable consumption |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fruit, vegetables, prevention, cancer, counseling, cancer risk