Personalized Nutrition Education in Improving Eating Habits of Healthy Participants Who Eat an Unhealthy Diet

NCT ID: NCT00301678

Last Updated: 2013-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2520 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30

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.

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: PREVENTION

Interventions

behavioral dietary intervention

Intervention Type: BEHAVIORAL

educational intervention

Intervention Type: OTHER

preventative dietary intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Principal Investigators

Kim M. Gans, PhD, MPH, LDN

Role: STUDY_CHAIR

Brown University

Locations

Brown University School of Medicine

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26445486 (View on PubMed)

Other Identifiers

BUSM -0348-03

Identifier Type: -

Identifier Source: secondary_id

RWMC-0348-03

Identifier Type: -

Identifier Source: secondary_id

CDR0000453539

Identifier Type: -

Identifier Source: org_study_id