Pre-diabetesNCT01479062
Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics
A study testing Alive-PD in people with Pre-diabetes and Diabetes, run by Berkeley Analytics, Inc. at 1 site in United States.
Trial summary
The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Pre-diabetes, Diabetes, Obesity
- What is being tested?
- Alive-PD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 339 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance
- at least one measurement of body mass index (BMI) >=27 in the past two years
- age 40-79
- no use of diabetes medications within the past two years
- member of Kaiser Permanente of Northern California (KPNC) for at least 2 years
- live in a 25 mile radius of the KPNC Research Clinic in Oakland, CA
Who cannot join
- comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation Research Institute
Palo Alto, California, 94301
About this study
Official title: Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
The trial will test whether the Alive multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.
- Conditions
- Pre-diabetes, Diabetes, Obesity
- Being tested
- Alive-PD, Usual Care
- Keywords
- behavior change, pre-diabetes, prevention, diabetes prevention, Hemoglobin A1c, glucose, physical activity, nutrition, email, web, obesity
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alive-PDBehavioural
Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
Usual CareBehavioural
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| participation in Alive-PD | Experimental | Alive-PD lifestyle intervention with multi-channel delivery Receives: Behavioral: Alive-PD |
| Control | Placebo comparator | Usual care Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body weight
Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months
Measured: at 3 months, 6 months and one year
Change from baseline in diabetes risk markers
Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months
Measured: at 3 months, 6 months and one year
Secondary outcomes (1)
Change from baseline in physical activity and dietary factors
Extent of change in physical activity and dietary factors as reported in questionnaires
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2011 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionDec 2015
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 Pre-diabetesStudies 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
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berkeley Analytics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Palo Alto Medical Foundation
- 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
- NCT01479062
- Sponsor's protocol ID
- 1R44NR012617-01
- Status last verified
- Jul 2016
- First submitted
- 22 Nov 2011
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, Block CH. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046.
PubMed 25608692Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.
PubMed 26499966
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Channel Automated Diet and Physical Activity Intervention for Pre-Diabetics (ALIVE-PD)
- ClinicalTrials.gov ID
- NCT01479062
- Acronym / sponsor ID
- 1R44NR012617-01
- Conditions
- Pre-diabetes, Diabetes, Obesity
- Keywords
- behavior change, pre-diabetes, prevention, diabetes prevention, Hemoglobin A1c, glucose, physical activity, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Berkeley Analytics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Palo Alto Medical Foundation
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Nov 2011 (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 multi-channel delivery health behavior program can positively affect weight and glucose level in pre-diabetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participation in Alive-PD | Experimental | Behavioral: Alive-PDAlive-PD lifestyle intervention with multi-channel delivery |
| Control | Placebo comparator | Behavioral: Usual CareUsual care |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least one measurement in past 2 yrs of fasting plasma glucose of 100-125 mg/dl or impaired glucose tolerance
- at least one measurement of body mass index (BMI) >=27 in the past two years
- age 40-79
- no use of diabetes medications within the past two years
- member of Kaiser Permanente of Northern California (KPNC) for at least 2 years
Key exclusion criteria (1 listed)
- comorbidities that would contraindicate the gradual adoption of light/moderate physical activity, such as a recent cardiovascular event, severe chronic obstructive pulmonary disease, advanced arthritis, or poorly controlled hypertension
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 |
|---|---|---|
| Alive-PDWeekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support | Behavioural | participation in Alive-PD |
| Usual CarePlacebo Control | Behavioural | Control |
Primary outcome
Change from baseline in body weight
Time frame: at 3 months, 6 months and one year
Mean weight loss and the proportion of subjects who achieve a 5% body weight loss at 3 and 6 months and maintain at 12 months
Change from baseline in diabetes risk markers
Time frame: at 3 months, 6 months and one year
Change in blood glucose level and hemoglobin A1c (HbA1c) as measured in clinic at 3 and 6 months and maintain at 12 months
1 secondary outcome
Change from baseline in physical activity and dietary factors
Time frame: 3 months and 12 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 18 Jan 2018.
- Background: PubMed 25608692Block G, Azar KM, Block TJ, Romanelli RJ, Carpenter H, Hopkins D, Palaniappan L, Block CH. A Fully Automated Diabetes Prevention Program, Alive-PD: Program Design and Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Jan 21;4(1):e3. doi: 10.2196/resprot.4046.
- Results publication: PubMed 26499966Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.
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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 Alive-PD in people with Pre-diabetes 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 6 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 18 Jan 2018. 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 from baseline in body weight (time frame: at 3 months, 6 months and one year). The study lists 2 primary outcomes in all. 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 NCT01479062, 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 18 Jan 2018.