The Fruit and Vegetable Study

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Behavioral: written materials only; Behavioral: written materials; Behavioral: telephone support

• Registration Number: NCT00468156
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-04-30
• Study First Submitted QC: 2007-04-30
• Study First Posted: 2007-05-02
• Primary Completion: 2007-09
• Study Completion: 2008-06
• Status Verified: 2008-11
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	written materials only	written materials only
2	written materials	written materials plus asked to form implementation intentions
3	telephone support	same as arm 2 plus telephone support

Primary Outcome Measures

Name	Time	Method
Document enrollment success at a primary care clinic	8 months

Secondary Outcome Measures

Name	Time	Method
Determine change in fruit and vegetable consumption	3 months

Trial Locations

Locations (1)

Ypsilanti Family Health Center; 🇺🇸 Ypsilanti, Michigan, United States