The Fruit and Vegetable Study

University of Michigan

Status: Completed

Conditions: Cancer

Treatments: Behavioral: telephone support; Behavioral: written materials only; Behavioral: written materials

Study type: Interventional

Funder types: Other

Identifiers

NCT00468156

HUM00004225

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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97 participants in 3 patient groups

1

Active Comparator group

Description:

written materials only

Treatment:

Behavioral: written materials only

2

Experimental group

Description:

written materials plus asked to form implementation intentions

Treatment:

Behavioral: written materials

3

Experimental group

Description:

same as arm 2 plus telephone support

Treatment:

Behavioral: telephone support