Skip to content

The Fruit and Vegetable Study

Implementation Intentions for Improving Fruit and Vegetable Intakes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00468156
Enrollment
97
Registered
2007-05-02
Start date
2006-09-30
Completion date
2008-06-30
Last updated
2012-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

fruit, vegetables, prevention, cancer, counseling, cancer risk

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.

Interventions

related to fruit/vegetable servings/day

related to fruit/vegetable servings/day

related to fruit/vegetable servings/day

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
Document enrollment success at a primary care clinic8 months

Secondary

MeasureTime frame
Determine change in fruit and vegetable consumption3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026