Cardiovascular DiseaseALIVENCT01233063
Diet and Activity Promotion Among Older Working Adults
A study testing Physical Activity and Diet Intervention via Alive2 in people with Cardiovascular Disease and Diabetes, run by Berkeley Analytics, Inc. at 1 site in United States.
Trial summary
The trial will test whether the Alive email-delivered health behavior program can improve subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Diabetes, Obesity
- What is being tested?
- Physical Activity and Diet Intervention via Alive2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 610 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2012
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 50+
- currently employed
- access to email/web
Who cannot join
- angina
Trial locations and contacts
1 site in 1 country.
United States1 site
Berkeley Analytics, Inc.
Berkeley, California, 94704
About this study
The trial will test whether the Alive email-delivered health behavior program can improve subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.
- Conditions
- Cardiovascular Disease, Diabetes, Obesity, Aging
- Being tested
- Physical Activity and Diet Intervention via Alive2
- Keywords
- behavior change, physical activity, nutrition, fruits and vegetables, saturated fat, trans fat, added sugars, email, web, obesity, aging
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity and Diet Intervention via Alive2Behavioural
Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.
| Study group | Role | What they receive |
|---|---|---|
| Alive2 | Experimental | Lifestyle Intervention delivered via email and web Receives: Behavioral: Physical Activity and Diet Intervention via Alive2 |
| Alive2 plus automated phone/print | Experimental | All of Arm 1 components, plus biweekly tailored automated phone coaching plus monthly tailored automated print materials. Receives: Behavioral: Physical Activity and Diet Intervention via Alive2 |
| Control | Placebo comparator | Monthly emailed newsletter on other aspects of wellness, excluding diet and physical activity Receives: Behavioral: Physical Activity and Diet Intervention via Alive2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
Change in physical activity as reported on questionnaire
Measured: 3, 6, 9, 12 months
Change in Fruits and Vegetables
Change in fruits and vegetables as reported on questionnaire
Measured: 3, 6, 9, 12 months
Change in saturated fats
Change in saturated fat intake as reported on questionnaire
Measured: 3, 6, 9, 12 months
Change in added sugar
Change in added sugar as reported on questionnaire
Measured: 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berkeley Analytics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Gladys Block, Berkeley Analytics, Inc.
- Investigators
- Gladys Block, PhD, Principal investigator, Berkeley Analytics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233063
- Sponsor's protocol ID
- 5R44AG032241-03
- Acronym
- ALIVE
- Status last verified
- Aug 2014
- First submitted
- 27 Oct 2010
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Activity Promotion Among Older Working Adults
- ClinicalTrials.gov ID
- NCT01233063
- Acronym / sponsor ID
- ALIVE / 5R44AG032241-03
- Conditions
- Cardiovascular Disease, Diabetes, Obesity, Aging
- Keywords
- behavior change, physical activity, nutrition, fruits and vegetables, saturated fat, trans fat, added sugars, email
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Berkeley Analytics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Nov 2010 (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 trial will test whether the Alive email-delivered health behavior program can improve subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alive2 | Experimental | Behavioral: Physical Activity and Diet Intervention via Alive2Lifestyle Intervention delivered via email and web |
| Alive2 plus automated phone/print | Experimental | Behavioral: Physical Activity and Diet Intervention via Alive2All of Arm 1 components, plus biweekly tailored automated phone coaching plus monthly tailored automated print materials. |
| Control | Placebo comparator | Behavioral: Physical Activity and Diet Intervention via Alive2Monthly emailed newsletter on other aspects of wellness, excluding diet and physical activity |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 50+
- currently employed
- access to email/web
Key exclusion criteria (1 listed)
- angina
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 |
|---|---|---|
| Physical Activity and Diet Intervention via Alive2Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support. | Behavioural | Alive2, Alive2 plus automated phone/print, Control |
Primary outcome
Change in physical activity
Time frame: 3, 6, 9, 12 months
Change in physical activity as reported on questionnaire
Change in Fruits and Vegetables
Time frame: 3, 6, 9, 12 months
Change in fruits and vegetables as reported on questionnaire
Change in saturated fats
Time frame: 3, 6, 9, 12 months
Change in saturated fat intake as reported on questionnaire
Change in added sugar
Time frame: 3, 6, 9, 12 months
Change in added sugar as reported on questionnaire
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 29 Aug 2014.
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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.
Gladys Block, PhD principal investigator
Berkeley Analytics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Diet Intervention via Alive2 in people with Cardiovascular Disease and Diabetes, run by Berkeley Analytics, Inc. 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 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 29 Aug 2014. 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. Some participants in this study may receive a placebo. 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: 3, 6, 9, 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2014.