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Implementation Intentions for Improving Fruit and Vegetable Intakes

40 Years
Not Enrolling

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Trial Information

Implementation Intentions for Improving Fruit and Vegetable Intakes

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.

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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Document enrollment success at a primary care clinic

Outcome Time Frame:

8 months

Safety Issue:


Principal Investigator

Zora Djuric, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

June 2008

Related Keywords:

  • Cancer
  • fruit
  • vegetables
  • prevention
  • cancer
  • counseling
  • cancer risk



Ypsilanti Family Health Center Ypsilanti, Michigan  48197