Unspecified Adult Solid Tumor, Protocol SpecificNCT00301678
Personalized Nutrition Education in Improving Eating Habits of 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, vegetable, and fiber intake may help prevent some types of cancer. Giving participants easy-to-read personalized written nutrition materials and a personalized 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
- 2,520 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to not given
- 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 participants who eat an unhealthy diet
- Employee at a work site
PATIENT CHARACTERISTICS:
- Able to speak and read English
- Not pregnant
- No acute or chronic medical condition that would prevent making basic healthful dietary changes
- Not already on healthy diet
- No significant visual and/or hearing impairments
- Not from the same household as another participant in this study
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: Innovative Video Tailoring for Dietary Change
RATIONALE: Decreasing the amount of fat in the diet and increasing fruit, vegetable, and fiber intake may help prevent some types of cancer. Giving participants easy-to-read personalized written nutrition materials and a personalized videotape may help improve eating habits.
PURPOSE: This clinical trial is studying how well personalized nutrition education improves the eating habits of healthy participants who eat an unhealthy diet.
Read the detailed description
OBJECTIVES:
- Develop and test an innovative intervention (tailored "take-home" video tapes with accompanying low literacy tailored written materials) to help participants improve their eating habits, particularly decreasing fat and increasing fiber, fruit, and vegetable intake.
- Determine the feasibility and acceptability of the above approach with work sites using process measures.
- Conduct a randomized controlled trial to test the effectiveness of this approach in achieving dietary change relevant to cancer prevention, as compared to written tailored materials only or usual care materials.
- Compare the differential costs of the above educational approaches.
- Study cognitive/behavioral (psychosocial) factors associated with decreasing fat and increasing fruit and vegetable consumption.
OUTLINE: This is a multicenter, controlled study.
Nutrition education materials will be mailed out in 3 different sets and will vary depending on which of three experimental conditions the company is assigned. The groups are: Non-Tailored Written (NT), Tailored Written (TW) , or Tailored Written and Video (TV).
- Group 1 (non-tailored written): Employee receives three sets of written information on nutrition and other health topics by mail. Upon completion of th study, participants in this group will receive a packet of written nutrition materials similar to what the other study groups received.
- Group 2 (tailored written): Employee receives three sets of tailored written nutrition materials in the mail. These written materials will be designed especially for each employee. They will be based on their answers to the first telephone survey, and from two later brief sets of questions.
- Group 3 (tailored written and video): Employee receives three sets of written nutrition materials and three videos or DVDs in the mail. The written materials and the video/DVD will be designed especially for each employee. They will be based on their answers to the first telephone survey and from two later brief sets of questions.
All participants receive booster intervention materials by mail at 2 and 4 months after baseline, following the same procedures as before. Participants receive follow-up telephone calls at 4 and 8 months after baseline.
PROJECTED ACCRUAL: A total of 2,520 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 8 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 8 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 startJun 2001
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
- 2,520 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
- NCT00301678
- Sponsor's protocol ID
- CDR0000453539
- Other IDs
- BUSM -0348-03, RWMC-0348-03
- Status last verified
- May 2007
- First submitted
- 9 Mar 2006
- Last updated
- 17 Sep 2013
- Results posted
- No
Publications
Gans KM, Risica PM, Dulin-Keita A, Mello J, Dawood M, Strolla LO, Harel O. Innovative video tailoring for dietary change: final results of the Good for you! cluster randomized trial. Int J Behav Nutr Phys Act. 2015 Oct 7;12:130. doi: 10.1186/s12966-015-0282-5.
PubMed 26445486
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Video Tailoring for Dietary Change
- ClinicalTrials.gov ID
- NCT00301678
- Acronym / sponsor ID
- CDR0000453539
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,520 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2001
- 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, vegetable, and fiber intake may help prevent some types of cancer. Giving participants easy-to-read personalized written nutrition materials and a personalized videotape may help improve eating habits.
PURPOSE: This clinical trial is studying how well personalized nutrition education improves the eating habits of healthy participants who eat an unhealthy diet.
Detailed description
OBJECTIVES:
- Develop and test an innovative intervention (tailored "take-home" video tapes with accompanying low literacy tailored written materials) to help participants improve their eating habits, particularly decreasing fat and increasing fiber, fruit, and vegetable intake.
- Determine the feasibility and acceptability of the above approach with work sites using process measures.
- Conduct a randomized controlled trial to test the effectiveness of this approach in achieving dietary change relevant to cancer prevention, as compared to written tailored materials only or usual care materials.
- Compare the differential costs of the above educational approaches.
- Study cognitive/behavioral (psychosocial) factors associated with decreasing fat and increasing fruit and vegetable consumption.
OUTLINE: This is a multicenter, controlled study.
Nutrition education materials will be mailed out in 3 different sets and will vary depending on which of three experimental conditions the company is assigned. The groups are: Non-Tailored Written (NT), Tailored Written (TW) , or Tailored Written and Video (TV).
- Group 1 (non-tailored written): Employee receives three sets of written information on nutrition and other health topics by mail. Upon completion of th study, participants in this group will receive a packet of written nutrition materials similar to what the other study groups received.
- Group 2 (tailored written): Employee receives three sets of tailored written nutrition materials in the mail. These written materials will be designed especially for each employee. They will be based on their answers to the first telephone survey, and from two later brief sets of questions.
- Group 3 (tailored written and video): Employee receives three sets of written nutrition materials and three videos or DVDs in the mail. The written materials and the video/DVD will be designed especially for each employee. They will be based on their answers to the first telephone survey and from two later brief sets of questions.
All participants receive booster intervention materials by mail at 2 and 4 months after baseline, following the same procedures as before. Participants receive follow-up telephone calls at 4 and 8 months after baseline.
PROJECTED ACCRUAL: A total of 2,520 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 8 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 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
- Derived from this study: PubMed 26445486Gans KM, Risica PM, Dulin-Keita A, Mello J, Dawood M, Strolla LO, Harel O. Innovative video tailoring for dietary change: final results of the Good for you! cluster randomized trial. Int J Behav Nutr Phys Act. 2015 Oct 7;12:130. doi: 10.1186/s12966-015-0282-5.
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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: status not confirmed, as of the sponsor's last update on 17 Sep 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?
Results are not available in the source record.
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 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 NCT00301678, 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 17 Sep 2013.