CancerPhase 1NCT00148525
The Study of Automated Telephone Programs for the Maintenance of Dietary Change
A Phase 1 study testing Social Cognitive Theory and goal system theory in people with Cancer, run by Robert H. Friedman at 1 site in United States.
Trial summary
The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Social Cognitive Theory and goal system theory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,049 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jul 2011
- Phase
- Phase 1
- 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
Who may be able to join
- Consume fewer than 5 fruits and vegetables per day.
- Understand conversational English
- Have the ability to use a telephone without assistance
Who cannot join
- Under 18 years of age
- Diagnosis of a health condition for which dietary recommendations in the would be contraindicated,
- Have cognitive impairment
- Have a terminal illness, recent myocardial infarction, current or former diagnosis of an eating disorder, pregnancy
- Consume > 5 servings of fruit and vegetable per day, or
- Plan to move away from the Boston area in less than 30 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of 2 TeleComputer Diet Change Maintenance Programs
The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. The programs will be designed to help individuals maintain a healthy diet change for a lifetime.
Read the detailed description
RCT is completed. However, the eligibility was 18 y/o or greater and living in Greater Boston area. The participants used an evidenced based dietary intervention for 3 months and then were randomized to 1 of 3 arms. Those in the experimental arm received a 6 mo intervention based on social cognitive theory or goal systems theory. The intervention was designed to help the participants maintain previously achieved changes in the their diet, e.g., fruits and vegetables. The outcome measures are fruit and vegetable consumption as measured by servings on multiple dietary measures as well as a 24 hr dietary recall.
- Conditions
- Cancer
- Being tested
- Social Cognitive Theory, goal system theory
- Keywords
- automated telephony, cancer prevention, healthy diet
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognitive TheoryBehavioural
Also called Social cognitive theory (SCT)
6 mo dietary intervention. This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory.
goal system theoryBehavioural
Also called Goal systems theory (GST)
This arm received a 6 mo diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory and delivered by an automated telephone system.
| Study group | Role | What they receive |
|---|---|---|
| social cognitive theory | Experimental | This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory and delivered by an automated telephone system. Receives: Behavioral: Social Cognitive Theory |
| Goal Systems Theory | Experimental | This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory. Receives: Behavioral: goal system theory |
| Comparison group | No intervention | comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption.
Measured: July 2006-July 2009
Secondary outcomes (1)
Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.
Measured: July 2006-July 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2006
- Primary completionAug 2010
- Study completionJul 2011
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 CancerStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert H. Friedman
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor-investigator, Robert H. Friedman, Boston Medical Center
- Investigators
- Robert Friedman, MD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148525
- Sponsor's protocol ID
- R01CA105832-02
- Other IDs
- National Cancer Institute
- Status last verified
- Jun 2011
- First submitted
- 6 Sep 2005
- Last updated
- 2 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wright JA, Quintiliani LM, Turner-McGrievy GM, Migneault JP, Heeren T, Friedman RH. Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial. JMIR Res Protoc. 2014 Nov 10;3(4):e62. doi: 10.2196/resprot.3367.
PubMed 25387065
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of 2 TeleComputer Diet Change Maintenance Programs
- ClinicalTrials.gov ID
- NCT00148525
- Acronym / sponsor ID
- R01CA105832-02
- Conditions
- Cancer
- Keywords
- automated telephony, cancer prevention, healthy diet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,049 participants (actual)
- Lead sponsor
- Robert H. FriedmanUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- Jul 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 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.
The purpose of this study is to test two different approaches to helping individuals who have recently starting eating a healthful diet maintain those healthy changes. This study will deliver a health program using an automated telephone system. The programs will be designed to help individuals maintain a healthy diet change for a lifetime.
Detailed description
RCT is completed. However, the eligibility was 18 y/o or greater and living in Greater Boston area. The participants used an evidenced based dietary intervention for 3 months and then were randomized to 1 of 3 arms. Those in the experimental arm received a 6 mo intervention based on social cognitive theory or goal systems theory. The intervention was designed to help the participants maintain previously achieved changes in the their diet, e.g., fruits and vegetables. The outcome measures are fruit and vegetable consumption as measured by servings on multiple dietary measures as well as a 24 hr dietary recall.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| social cognitive theory | Experimental | Behavioral: Social Cognitive TheoryThis arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory and delivered by an automated telephone system. |
| Goal Systems Theory | Experimental | Behavioral: goal system theoryThis arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory. |
| Comparison group | No intervention | –comparison group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consume fewer than 5 fruits and vegetables per day.
- Understand conversational English
- Have the ability to use a telephone without assistance
Key exclusion criteria (6 listed)
- Under 18 years of age
- Diagnosis of a health condition for which dietary recommendations in the would be contraindicated,
- Have cognitive impairment
- Have a terminal illness, recent myocardial infarction, current or former diagnosis of an eating disorder, pregnancy
- Consume > 5 servings of fruit and vegetable per day, or
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 |
|---|---|---|
| Social Cognitive TheoryAlso: Social cognitive theory (SCT)6 mo dietary intervention. This arm received an diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on social cognitive theory. | Behavioural | social cognitive theory |
| goal system theoryAlso: Goal systems theory (GST)This arm received a 6 mo diet intervention designed to maintain changes in fruit and vegetable consumption. The intervention components were based on goal systems theory and delivered by an automated telephone system. | Behavioural | Goal Systems Theory |
Primary outcome
The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption.
Time frame: July 2006-July 2009
1 secondary outcome
Intervention effects will be mediated by behavioral factors predicted by Social Cognitive Theory and Goal Systems Theory.
Time frame: July 2006-July 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2015.
- Derived from this study: PubMed 25387065Wright JA, Quintiliani LM, Turner-McGrievy GM, Migneault JP, Heeren T, Friedman RH. Comparison of two theory-based, fully automated telephone interventions designed to maintain dietary change in healthy adults: study protocol of a three-arm randomized controlled trial. JMIR Res Protoc. 2014 Nov 10;3(4):e62. doi: 10.2196/resprot.3367.
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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.
Robert Friedman, MD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Social Cognitive Theory and goal system theory in people with Cancer, run by Robert H. Friedman 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?
The sponsor lists 3 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 2 Jul 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The study hypothesis is that the goal systems intervention will out perform the social cognitive intervention and that both of these interventions will outperform the control group for fruit and vegetable consumption. (time frame: July 2006-July 2009). 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 NCT00148525, 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 2 Jul 2015.