InactivityNCT00607009
Project ALIVE (A Lifestyle Intervention Via Email)
A study testing ALIVE in people with Inactivity, run by Kaiser Permanente.
Trial summary
The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inactivity
- What is being tested?
- ALIVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 797 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to May 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
Who may be able to join
- regional Northern California KP employees
Who cannot join
- none
About this study
Official title: Email-Based Diet and Activity Promotion in Worksites
The objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.
- Conditions
- Inactivity
- Being tested
- ALIVE
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIVEBehavioural
ALIVE email-based behavioral program based on the participants selected intervention - physical activity, fats/sugars or fruits/vegetabls
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | ALIVE - received emails about chosen behavioral intervention path - physical activity, fruits/vegetables or fats/sugars Receives: Behavioral: ALIVE |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in physical activity
Measured: 4 months
Secondary outcomes (5)
change in fruits and vegetables
Measured: 4 months
health-related quality of life
Measured: 4 months
presentism
Measured: 4 months
stage of change
Measured: 4 months
self efficacy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJul 2006
- Primary completionMay 2007
- Study completionMay 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 InactivityStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Barbara Sternfeld, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607009
- Sponsor's protocol ID
- CN-04BSter-02-H
- Other IDs
- 5R01DP000095-03
- Status last verified
- Apr 2019
- First submitted
- 22 Jan 2008
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sternfeld B, Block C, Quesenberry CP Jr, Block TJ, Husson G, Norris JC, Nelson M, Block G. Improving diet and physical activity with ALIVE: a worksite randomized trial. Am J Prev Med. 2009 Jun;36(6):475-83. doi: 10.1016/j.amepre.2009.01.036.
PubMed 19460655Block G, Sternfeld B, Block CH, Block TJ, Norris J, Hopkins D, Quesenberry CP Jr, Husson G, Clancy HA. Development of Alive! (A Lifestyle Intervention Via Email), and its effect on health-related quality of life, presenteeism, and other behavioral outcomes: randomized controlled trial. J Med Internet Res. 2008 Nov 19;10(4):e43. doi: 10.2196/jmir.1112.
PubMed 19019818
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Email-Based Diet and Activity Promotion in Worksites
- ClinicalTrials.gov ID
- NCT00607009
- Acronym / sponsor ID
- CN-04BSter-02-H
- Conditions
- Inactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 797 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jul 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 5 Feb 2008 (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 objective of this study is to test the effectiveness of an email-based diet and physical activity intervention on increasing physical activity and fruit and vegetable consumption and decreasing intake of saturated and trans fats and added sugars.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ALIVEALIVE - received emails about chosen behavioral intervention path - physical activity, fruits/vegetables or fats/sugars |
| Control | No intervention | –no intervention |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- regional Northern California KP employees
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| ALIVEALIVE email-based behavioral program based on the participants selected intervention - physical activity, fats/sugars or fruits/vegetabls | Behavioural | Intervention |
Primary outcome
change in physical activity
Time frame: 4 months
5 secondary outcomes
change in fruits and vegetables
Time frame: 4 months
health-related quality of life
Time frame: 4 months
presentism
Time frame: 4 months
stage of change
Time frame: 4 months
self efficacy
Time frame: 4 months
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 24 Apr 2019.
- Derived from this study: PubMed 19460655Sternfeld B, Block C, Quesenberry CP Jr, Block TJ, Husson G, Norris JC, Nelson M, Block G. Improving diet and physical activity with ALIVE: a worksite randomized trial. Am J Prev Med. 2009 Jun;36(6):475-83. doi: 10.1016/j.amepre.2009.01.036.
- Derived from this study: PubMed 19019818Block G, Sternfeld B, Block CH, Block TJ, Norris J, Hopkins D, Quesenberry CP Jr, Husson G, Clancy HA. Development of Alive! (A Lifestyle Intervention Via Email), and its effect on health-related quality of life, presenteeism, and other behavioral outcomes: randomized controlled trial. J Med Internet Res. 2008 Nov 19;10(4):e43. doi: 10.2196/jmir.1112.
- Prevent diabetes: NutritionQuest's new intervention program, Alive-PD. See Dr. Block's presentation on results of randomized trialLink provided by the sponsor.
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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.
Barbara Sternfeld, PhD principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
A study testing ALIVE in people with Inactivity, run by Kaiser Permanente.
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 1 inclusion and 1 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
change in physical activity (time frame: 4 months). 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 NCT00607009, 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 24 Apr 2019.