NCT00468156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

December 20, 2012

Status Verified

November 1, 2008

Enrollment Period

1 year

First QC Date

April 30, 2007

Last Update Submit

December 19, 2012

Conditions

Cancer

Keywords

fruitvegetablespreventioncancercounselingcancer risk

Outcome Measures

Primary Outcomes (1)

  • Document enrollment success at a primary care clinic

    8 months

Secondary Outcomes (1)

  • Determine change in fruit and vegetable consumption

    3 months

Study Arms (3)

1

ACTIVE COMPARATOR

written materials only

Behavioral: written materials only

2

EXPERIMENTAL

written materials plus asked to form implementation intentions

Behavioral: written materials

3

EXPERIMENTAL

same as arm 2 plus telephone support

Behavioral: telephone support

Interventions

written materials onlyBEHAVIORAL

related to fruit/vegetable servings/day

Also known as: control
1
written materialsBEHAVIORAL

related to fruit/vegetable servings/day

Also known as: asked to form implementation intentions
2
telephone supportBEHAVIORAL

related to fruit/vegetable servings/day

Also known as: written plus telephone
3

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 and older
  • Give informed consent
  • In general good health
  • Less than 5.5 servings/day of fruits and vegetables

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ypsilanti Family Health Center

Ypsilanti, Michigan, 48197, United States

Location

Related 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.

    PMID: 20226809RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Zora Djuric, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

April 30, 2007

First Posted

May 2, 2007

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

June 1, 2008

Last Updated

December 20, 2012

Record last verified: 2008-11

Locations

US(1)