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Clinical Trials/NCT00468156
NCT00468156
Completed
N/A

Implementation Intentions for Improving Fruit and Vegetable Intakes

University of Michigan1 site in 1 country97 target enrollmentSeptember 2006
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Michigan
Enrollment
97
Locations
1
Primary Endpoint
Document enrollment success at a primary care clinic
Status
Completed
Last Updated
13 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
June 2008
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zora Djuric

Research Professor

University of Michigan

Eligibility 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).

Outcomes

Primary Outcomes

Document enrollment success at a primary care clinic

Time Frame: 8 months

Secondary Outcomes

  • Determine change in fruit and vegetable consumption(3 months)

Study Sites (1)

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