Unspecified Adult Solid Tumor, Protocol SpecificNCT00169312
Internet-Based Nutrition Education Program in Preventing Cancer in Participants of Health Maintenance Organizations
A study testing behavioral dietary intervention, dietary intervention and educational intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Josephine Ford Cancer Center at 4 sites in United States.
Trial summary
RATIONALE: Websites for nutrition education may be an effective method to help people eat more fruits and vegetables which may lower their risk of cancer. PURPOSE: This randomized trial is studying how well an internet-based nutrition education program works in preventing cancer in participants of health maintenance… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- behavioral dietary intervention, dietary intervention and educational intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 2,619 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2005to Jun 2007
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kaiser Permanente, Georgia
Atlanta, Georgia
Kaiser Permanente - Colorado
Denver, Colorado
HealthPartners Research Foundation
Minneapolis, Minnesota
Group Health Cooperative
Seattle, Washington, 98101
About this study
Official title: The HMO Cancer Research Network (CRN) - Making Effective Nutritional Choices for Cancer Prevention: The MENU Study
RATIONALE: Websites for nutrition education may be an effective method to help people eat more fruits and vegetables which may lower their risk of cancer.
PURPOSE: This randomized trial is studying how well an internet-based nutrition education program works in preventing cancer in participants of health maintenance organizations.
Read the detailed description
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.
- Being tested
- behavioral dietary intervention, dietary intervention, educational intervention, internet-based 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
dietary interventionDietary supplement
educational interventionOther
internet-based interventionOther
preventative dietary interventionOther
evaluation of cancer risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention
Secondary outcomes (2)
Change in the number of daily fruit and vegetable servings consumed at the 3- and 6-month post-intervention assessments
Proportion of participants who achieve an intake of 5 or more daily fruit and vegetable servings by 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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.
- 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
- Allocation
- Randomised
- Masking
- Single blind
- Enrolment
- 2,619 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josephine Ford Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Christine Cole Johnson, PhD, Principal investigator, Josephine Ford Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169312
- Sponsor's protocol ID
- CDR0000514226
- Other IDs
- HFH-B40389
- Status last verified
- Sep 2009
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2013
- Results posted
- No
Publications
Stopponi MA, Alexander GL, McClure JB, Carroll NM, Divine GW, Calvi JH, Rolnick SJ, Strecher VJ, Johnson CC, Ritzwoller DP. Recruitment to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants. J Med Internet Res. 2009 Aug 26;11(3):e38. doi: 10.2196/jmir.1086.
PubMed 19709990Couper MP, Alexander GL, Zhang N, Little RJ, Maddy N, Nowak MA, McClure JB, Calvi JJ, Rolnick SJ, Stopponi MA, Cole Johnson C. Engagement and retention: measuring breadth and depth of participant use of an online intervention. J Med Internet Res. 2010 Nov 18;12(4):e52. doi: 10.2196/jmir.1430.
PubMed 21087922
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HMO Cancer Research Network (CRN) - Making Effective Nutritional Choices for Cancer Prevention: The MENU Study
- ClinicalTrials.gov ID
- NCT00169312
- Acronym / sponsor ID
- CDR0000514226
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,619 participants (estimated)
- Lead sponsor
- Josephine Ford Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2005
- Study completion
- Jun 2007
- First posted
- 15 Sep 2005 (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: Websites for nutrition education may be an effective method to help people eat more fruits and vegetables which may lower their risk of cancer.
PURPOSE: This randomized trial is studying how well an internet-based nutrition education program works in preventing cancer in participants of health maintenance organizations.
Detailed description
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.
Study design
- Allocation
- Randomised
- Masking
- Single blind
Who may qualify
- Ages
- 21 to 65 years
- 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 | – |
| dietary intervention | Dietary supplement | – |
| educational intervention | Other | – |
| internet-based intervention | Other | – |
| preventative dietary intervention | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention
2 secondary outcomes
Change in the number of daily fruit and vegetable servings consumed at the 3- and 6-month post-intervention assessments
Proportion of participants who achieve an intake of 5 or more daily fruit and vegetable servings by 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Background: PubMed 19709990Stopponi MA, Alexander GL, McClure JB, Carroll NM, Divine GW, Calvi JH, Rolnick SJ, Strecher VJ, Johnson CC, Ritzwoller DP. Recruitment to a randomized web-based nutritional intervention trial: characteristics of participants compared to non-participants. J Med Internet Res. 2009 Aug 26;11(3):e38. doi: 10.2196/jmir.1086.
- Derived from this study: PubMed 21087922Couper MP, Alexander GL, Zhang N, Little RJ, Maddy N, Nowak MA, McClure JB, Calvi JJ, Rolnick SJ, Stopponi MA, Cole Johnson C. Engagement and retention: measuring breadth and depth of participant use of an online intervention. J Med Internet Res. 2010 Nov 18;12(4):e52. doi: 10.2196/jmir.1430.
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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.
Christine Cole Johnson, PhD principal investigator
Josephine Ford Cancer Center
4 sites 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, dietary intervention and educational intervention in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Josephine Ford Cancer Center at 4 sites 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 20 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 4 sites 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?
Change in the number of daily fruit and vegetable servings consumed from baseline to 12 months post intervention. 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 NCT00169312, which also lists 2 linked publications.
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 20 Sep 2013.