The Fruit and Vegetable Study

Cancer Clinical Trial

Official title:

Implementation Intentions for Improving Fruit and Vegetable Intakes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468156
• Other study ID #: HUM00004225
• Status: Completed
• Phase: N/A
• First received: April 30, 2007
• Last updated: December 19, 2012
• Start date: September 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2008
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• written materials only
related to fruit/vegetable servings/day
• written materials
related to fruit/vegetable servings/day
• telephone support
related to fruit/vegetable servings/day

Locations

Country	Name	City	State
United States	Ypsilanti Family Health Center	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Djuric Z, Ellsworth JS, Ren J, Sen A, Ruffin MT 4th. A randomized feasibility trial of brief telephone counseling to increase fruit and vegetable intakes. Prev Med. 2010 May-Jun;50(5-6):265-71. doi: 10.1016/j.ypmed.2010.03.003. Epub 2010 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document enrollment success at a primary care clinic		8 months	No
Secondary	Determine change in fruit and vegetable consumption		3 months	No