- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01233063
Diet and Activity Promotion Among Older Working Adults (ALIVE)
August 28, 2014 updated by: Gladys Block, Berkeley Analytics, Inc.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
610
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Berkeley, California, United States, 94704
- Berkeley Analytics, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 50+
- currently employed
- access to email/web
Exclusion Criteria:
- angina
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Alive2
Lifestyle Intervention delivered via email and web
|
Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.
|
Experimental: Alive2 plus automated phone/print
All of Arm 1 components, plus biweekly tailored automated phone coaching plus monthly tailored automated print materials.
|
Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.
|
Placebo Comparator: Control
Monthly emailed newsletter on other aspects of wellness, excluding diet and physical activity
|
Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in physical activity
Time Frame: 3, 6, 9, 12 months
|
Change in physical activity as reported on questionnaire
|
3, 6, 9, 12 months
|
Change in Fruits and Vegetables
Time Frame: 3, 6, 9, 12 months
|
Change in fruits and vegetables as reported on questionnaire
|
3, 6, 9, 12 months
|
Change in saturated fats
Time Frame: 3, 6, 9, 12 months
|
Change in saturated fat intake as reported on questionnaire
|
3, 6, 9, 12 months
|
Change in added sugar
Time Frame: 3, 6, 9, 12 months
|
Change in added sugar as reported on questionnaire
|
3, 6, 9, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gladys Block, PhD, Berkeley Analytics, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
October 27, 2010
First Submitted That Met QC Criteria
November 1, 2010
First Posted (Estimate)
November 3, 2010
Study Record Updates
Last Update Posted (Estimate)
August 29, 2014
Last Update Submitted That Met QC Criteria
August 28, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R44AG032241-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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