Unspecified Adult Solid Tumor, Protocol SpecificNCT00301691
Nutrition Education for Low-Income Healthy Participants Who Eat an Unhealthy Diet
A study testing behavioral dietary intervention, educational intervention and preventative dietary intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Brown University at 1 site in United States.
Trial summary
RATIONALE: Decreasing the amount of fat in the diet and increasing fruit and vegetable intake may help prevent some types of cancer. Giving low-income participants easy-to-read written nutrition materials and an instructional and motivational videotape may help improve eating habits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- behavioral dietary intervention, educational intervention and preventative dietary intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to May 2006
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Healthy low income participant who eats an unhealthy diet
- Not already on a healthy diet
PATIENT CHARACTERISTICS:
- Able to read basic Spanish or English
- Not pregnant
- No acute or chronic medical condition which would prevent participant from making basic healthful dietary changes
- No significant visual and/or hearing impairments
- Not from the same household as another study participant
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Medicine
Providence, Rhode Island, 02903
About this study
Official title: Tailoring Nutrition Education for Low-Income Audiences
RATIONALE: Decreasing the amount of fat in the diet and increasing fruit and vegetable intake may help prevent some types of cancer. Giving low-income participants easy-to-read written nutrition materials and an instructional and motivational videotape may help improve eating habits.
PURPOSE: This randomized clinical trial is studying how well nutrition education improves the eating habits of low-income healthy participants who eat an unhealthy diet.
Read the detailed description
OBJECTIVES:
- Test culturally and linguistically appropriate English and Spanish language versions of a motivational and instructional video and low literacy written nutrition materials that focus on improving eating habits, particularly decreasing fat consumption and increasing fruit and vegetable intake in non-Hispanic and Hispanic low-income participants, to determine which intervention components are most effective in decreasing fat intake and increasing fruit and vegetable intake.
- Determine if participants who receive tailored nutrition information in several mailings (MT) decrease their fat consumption and increase their fruit and vegetable intake more than participants who receive such information in one mailing (ST).
- Determine if participants who receive tailored nutrition information in several sequential "interactively retailored" mailings (MTI) decrease their fat consumption and increase their fruit and vegetable intake more than MT participants.
- Compare dietary change achieved from the above tailored educational approaches with a comparison group that receives nontailored written nutritional materials (NT).
- Compare the differential costs of the above tailored educational approaches.
- Study the results of the randomized trial in terms of specific eating behaviors, stage of change, self-efficacy, decisional balance, and barriers to making dietary changes.
OUTLINE: This is a randomized, controlled study.
Participants complete a baseline interview. A subset of participants completes a second interview at baseline. Participants are then randomized to 1 of 4 education arms.
- Arm I (non-tailored written nutrition materials): Participants receive non-tailored written nutrition information in 1 installment.
- Arm II (tailored nutrition information): Participants receive tailored written nutrition information in 1 installment. Participants also receive a motivational and instructional video.
- Arm III (tailored nutrition information in multiple mailings): Participants receive tailored written nutrition information in 4 smaller installments over 12 weeks. Participants also receive a motivational and instructional video.
- Arm IV (multiple sequential "interactively tailored" mailings): Participants receive tailored written nutrition information and a motivational and instructional video as in arm III. Participants may mail in follow-up assessments in order to retailor the information they receive in later installments.
After completion of study intervention, patients are followed at 4 and 7 months.
PROJECTED ACCRUAL: A total of 2,000 participants will be accrued for this study.
- Being tested
- behavioral dietary intervention, educational intervention, preventative dietary intervention
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
educational interventionOther
preventative dietary interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 7 months
Secondary outcomes (1)
Mediators and moderators of behavioral change by adapted scales for stage of change, self-efficacy, barriers, and facilitators at baseline, 4 months, and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2006 (estimated)
- Study startSep 2000
- Study completionMay 2006
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 Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe 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
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Kim M. Gans, PhD, MPH, LDN, Study chair, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301691
- Sponsor's protocol ID
- BUSM-R01-CA81828
- Other IDs
- CDR0000453534
- Status last verified
- May 2006
- First submitted
- 9 Mar 2006
- Last updated
- 10 Jul 2013
- Results posted
- No
Publications
Gans KM, Risica PM, Strolla LO, Fournier L, Kirtania U, Upegui D, Zhao J, George T, Acharyya S. Effectiveness of different methods for delivering tailored nutrition education to low income, ethnically diverse adults. Int J Behav Nutr Phys Act. 2009 May 5;6:24. doi: 10.1186/1479-5868-6-24.
PubMed 19416525
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring Nutrition Education for Low-Income Audiences
- ClinicalTrials.gov ID
- NCT00301691
- Acronym / sponsor ID
- BUSM-R01-CA81828
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2000
- Study completion
- May 2006 (actual)
- First posted
- 13 Mar 2006 (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.
RATIONALE: Decreasing the amount of fat in the diet and increasing fruit and vegetable intake may help prevent some types of cancer. Giving low-income participants easy-to-read written nutrition materials and an instructional and motivational videotape may help improve eating habits.
PURPOSE: This randomized clinical trial is studying how well nutrition education improves the eating habits of low-income healthy participants who eat an unhealthy diet.
Detailed description
OBJECTIVES:
- Test culturally and linguistically appropriate English and Spanish language versions of a motivational and instructional video and low literacy written nutrition materials that focus on improving eating habits, particularly decreasing fat consumption and increasing fruit and vegetable intake in non-Hispanic and Hispanic low-income participants, to determine which intervention components are most effective in decreasing fat intake and increasing fruit and vegetable intake.
- Determine if participants who receive tailored nutrition information in several mailings (MT) decrease their fat consumption and increase their fruit and vegetable intake more than participants who receive such information in one mailing (ST).
- Determine if participants who receive tailored nutrition information in several sequential "interactively retailored" mailings (MTI) decrease their fat consumption and increase their fruit and vegetable intake more than MT participants.
- Compare dietary change achieved from the above tailored educational approaches with a comparison group that receives nontailored written nutritional materials (NT).
- Compare the differential costs of the above tailored educational approaches.
- Study the results of the randomized trial in terms of specific eating behaviors, stage of change, self-efficacy, decisional balance, and barriers to making dietary changes.
OUTLINE: This is a randomized, controlled study.
Participants complete a baseline interview. A subset of participants completes a second interview at baseline. Participants are then randomized to 1 of 4 education arms.
- Arm I (non-tailored written nutrition materials): Participants receive non-tailored written nutrition information in 1 installment.
- Arm II (tailored nutrition information): Participants receive tailored written nutrition information in 1 installment. Participants also receive a motivational and instructional video.
- Arm III (tailored nutrition information in multiple mailings): Participants receive tailored written nutrition information in 4 smaller installments over 12 weeks. Participants also receive a motivational and instructional video.
- Arm IV (multiple sequential "interactively tailored" mailings): Participants receive tailored written nutrition information and a motivational and instructional video as in arm III. Participants may mail in follow-up assessments in order to retailor the information they receive in later installments.
After completion of study intervention, patients are followed at 4 and 7 months.
PROJECTED ACCRUAL: A total of 2,000 participants will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| behavioral dietary intervention | Behavioural | – |
| educational intervention | Other | – |
| preventative dietary intervention | Other | – |
Primary outcome
Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 7 months
1 secondary outcome
Mediators and moderators of behavioral change by adapted scales for stage of change, self-efficacy, barriers, and facilitators at baseline, 4 months, and 7 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 10 Jul 2013.
- Derived from this study: PubMed 19416525Gans KM, Risica PM, Strolla LO, Fournier L, Kirtania U, Upegui D, Zhao J, George T, Acharyya S. Effectiveness of different methods for delivering tailored nutrition education to low income, ethnically diverse adults. Int J Behav Nutr Phys Act. 2009 May 5;6:24. doi: 10.1186/1479-5868-6-24.
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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.
Kim M. Gans, PhD, MPH, LDN study chair
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral dietary intervention, educational intervention and preventative dietary intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Brown University 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?
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 10 Jul 2013. 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?
Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 7 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 NCT00301691, 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 10 Jul 2013.