CancerNCT00468156
The Fruit and Vegetable Study
A study testing written materials only, written materials and telephone support in people with Cancer, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- written materials only, written materials and telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40 and older
- Give informed consent
- In general good health
- Less than 5.5 servings/day of fruits and vegetables
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Ypsilanti Family Health Center
Ypsilanti, Michigan, 48197
About this study
Official title: Implementation Intentions for Improving Fruit and Vegetable Intakes
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- written materials only, written materials, telephone support
- Keywords
- fruit, vegetables, prevention, cancer, counseling, cancer risk
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
written materials onlyBehavioural
Also called control
related to fruit/vegetable servings/day
written materialsBehavioural
Also called asked to form implementation intentions
related to fruit/vegetable servings/day
telephone supportBehavioural
Also called written plus telephone
related to fruit/vegetable servings/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | written materials only Receives: Behavioral: written materials only |
| 2 | Experimental | written materials plus asked to form implementation intentions Receives: Behavioral: written materials |
| 3 | Experimental | same as arm 2 plus telephone support Receives: Behavioral: telephone support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Document enrollment success at a primary care clinic
Measured: 8 months
Secondary outcomes (1)
Determine change in fruit and vegetable consumption
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zora Djuric, University of Michigan
- Investigators
- Zora Djuric, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468156
- Sponsor's protocol ID
- HUM00004225
- Status last verified
- Nov 2008
- First submitted
- 30 Apr 2007
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20226809
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Intentions for Improving Fruit and Vegetable Intakes
- ClinicalTrials.gov ID
- NCT00468156
- Acronym / sponsor ID
- HUM00004225
- Conditions
- Cancer
- Keywords
- fruit, vegetables, prevention, cancer, counseling, cancer risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: written materials onlywritten materials only |
| 2 | Experimental | Behavioral: written materialswritten materials plus asked to form implementation intentions |
| 3 | Experimental | Behavioral: telephone supportsame as arm 2 plus telephone support |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40 and older
- Give informed consent
- In general good health
- Less than 5.5 servings/day of fruits and vegetables
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| written materials onlyAlso: controlrelated to fruit/vegetable servings/day | Behavioural | 1 |
| written materialsAlso: asked to form implementation intentionsrelated to fruit/vegetable servings/day | Behavioural | 2 |
| telephone supportAlso: written plus telephonerelated to fruit/vegetable servings/day | Behavioural | 3 |
Primary outcome
Document enrollment success at a primary care clinic
Time frame: 8 months
1 secondary outcome
Determine change in fruit and vegetable consumption
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2012.
- Results publication: PubMed 20226809Djuric 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zora Djuric, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing written materials only, written materials and telephone support in people with Cancer, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document enrollment success at a primary care clinic (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2012.