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The Fruit and Vegetable Study

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ClinicalTrials.gov Identifier: NCT00468156
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : December 20, 2012
Sponsor:
Information provided by (Responsible Party):
Zora Djuric, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Behavioral: written materials only Behavioral: written materials Behavioral: telephone support Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementation Intentions for Improving Fruit and Vegetable Intakes
Study Start Date : September 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Active Comparator: 1
written materials only
Behavioral: written materials only
related to fruit/vegetable servings/day
Other Name: control
Experimental: 2
written materials plus asked to form implementation intentions
Behavioral: written materials
related to fruit/vegetable servings/day
Other Name: asked to form implementation intentions
Experimental: 3
same as arm 2 plus telephone support
Behavioral: telephone support
related to fruit/vegetable servings/day
Other Name: written plus telephone



Primary Outcome Measures :
  1. Document enrollment success at a primary care clinic [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Determine change in fruit and vegetable consumption [ Time Frame: 3 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00468156


Locations
United States, Michigan
Ypsilanti Family Health Center
Ypsilanti, Michigan, United States, 48197
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Zora Djuric, PhD University of Michigan

Publications of Results:
Responsible Party: Zora Djuric, Research Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00468156     History of Changes
Other Study ID Numbers: HUM00004225
First Posted: May 2, 2007    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: November 2008

Keywords provided by Zora Djuric, University of Michigan:
fruit
vegetables
prevention
cancer
counseling
cancer risk