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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 9, 2006 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | June 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 8 months [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Dietary assessment by modified Family Habits Questionnaire (FHQ), FVFQ, and Food Frequency Questionnaire (FFQ) at baseline, 4 months, and 8 months | ||||
| Change History | Complete list of historical versions of study NCT00301678 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
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 | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Personalized Nutrition Education in Improving Eating Habits of Healthy Participants Who Eat an Unhealthy Diet | ||||
| Official Title ICMJE | Innovative Video Tailoring for Dietary Change | ||||
| Brief 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. PURPOSE: This clinical trial is studying how well personalized nutrition education improves the eating habits of healthy participants who eat an unhealthy diet. |
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| Detailed Description | OBJECTIVES:
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).
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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Active Control | ||||
| Condition ICMJE | Unspecified Adult Solid Tumor, Protocol Specific | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 2520 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00301678 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000453539, BUSM -0348-03, RWMC-0348-03 | ||||
| Study Sponsor ICMJE | Brown University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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