The Fruit and Vegetable Study

December 19, 2012 updated by: Zora Djuric, University of Michigan

Implementation Intentions for Improving Fruit and Vegetable Intakes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Ypsilanti Family Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Document enrollment success at a primary care clinic
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine change in fruit and vegetable consumption
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Zora Djuric, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 30, 2007

First Submitted That Met QC Criteria

April 30, 2007

First Posted (Estimate)

May 2, 2007

Study Record Updates

Last Update Posted (Estimate)

December 20, 2012

Last Update Submitted That Met QC Criteria

December 19, 2012

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00004225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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