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The HMO Cancer Research Network (CRN) - Making Effective Nutritional Choices for Cancer Prevention: The MENU Study


N/A
21 Years
65 Years
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

The HMO Cancer Research Network (CRN) - Making Effective Nutritional Choices for Cancer Prevention: The MENU Study


OBJECTIVES:

Primary

- Compare the effects of internet-based nutrition education through untailored websites
vs tailored websites (TW) vs TW and tailored human online behavioral interaction (HOBI)
on the change in the number of daily fruit and vegetable servings consumed in
participants of health maintenance organizations.

Secondary

- Compare the proportion of participants reporting consumption of 5 or more servings of
fruits and vegetables per day at each 3-month interval.

- Compare the change in fruit and vegetable servings consumed from baseline to each
intermediate time point.

- Compare the effects of intervention and observation time in these participants.

- Determine the effect of HOBI in these participants.

- Compare the impact of participant characteristics, in terms of the effect of the
intervention on the change in fruit and vegetable intake, in these participants.

OUTLINE: This is a randomized, controlled, single-blind, multicenter study. Participants are
stratified according to participating site, gender, and the participant's stage of change
readiness. Participants are randomized to 1 of 3 intervention arms.

- Arm I (untailored websites): Participants are given unlimited access to an
internet-based nutrition education program for up to 6 months. They are provided with 4
serial educational websites at 1, 3, 13, and 15 weeks after initial login. These
internet sites provide general information about fruits and vegetables, new recipes
with emphasis on fruits and vegetables, and how participants can incorporate them into
their diet. Participants complete an online survey at 3 months.

- Arm II (tailored websites): Participants are given unlimited access to an
internet-based nutrition education program for up to 6 months. They are provided with 4
serial educational websites, at the same timepoints as in arm I, with emphasis on
vegetable consumption in weeks 1 and 13 and fruit consumption in weeks 3 and 15.
Materials in these websites, including new recipes with emphasis on fruits and
vegetables, are tailored and then revised (or retailored) based on individual
health-risk information obtained at baseline and at the 3-month online survey.

- Arm III (tailored websites and human online behavioral interaction [HOBI]):
Participants are given unlimited access to an internet-based nutrition education
program for up to 6 months. Participants are provided with 4 serial educational
websites with tailored materials as in arm II. They also receive HOBI (tailored e-mail
messages) developed and then revised based on health-risk information obtained at
baseline and the 3-month online survey.

In all arms, participants complete online surveys at 3, 6, and 12 months to measure fruit
and vegetable intake and change in long-term risk behavior. For each survey, participants
receive up to 6 automatically generated reminder e-mails and 1 mailed announcement.

PROJECTED ACCRUAL: A total of 2,619 participants were accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Current member of any of the following participating health maintenance
organizations:

- Group Health Cooperative

- Kaiser Permanente, Colorado

- Kaiser Permanante, Georgia

- HealthPartners Research Foundation

- Henry Ford Health System/Health Alliance Plan

- Must complete a web-based health survey prior to randomization

PATIENT CHARACTERISTICS:

- No medical or mental health condition that would be adversely affected by increased
vegetable and fruit intake

- One participant allowed per household

PRIOR CONCURRENT THERAPY:

- No concurrent anticoagulation therapy (e.g., warfarin)

- No other concurrent medications that would be adversely affected by increased
vegetable and fruit intake

- No grapefruit concurrently with any of the following medications:

- Statin for high cholesterol

- Blood pressure medications (e.g., Losartan)

- Calcium channel blockers

- Certain psychiatric medications (e.g., buspirone hydrochloride, triazolam
[Halcion], carbamazepine, diazepam [Valium], or midazolam hydrochloride)

- Immune suppressants (e.g., cyclosporine or tacrolimus)

- Impotence medications (e.g., sildenafil [Viagra])

- Methadone

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Single Blind

Outcome Measure:

Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention

Safety Issue:

No

Principal Investigator

Christine Cole Johnson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Josephine Ford Cancer Center at Henry Ford Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000514226

NCT ID:

NCT00169312

Start Date:

August 2005

Completion Date:

June 2007

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific

Name

Location

Group Health CooperativeSeattle, Washington  98112
Kaiser Permanente - ColoradoDenver, Colorado  
Kaiser Permanente, GeorgiaAtlanta, Georgia  
HealthPartners Research FoundationMinneapolis, Minnesota