DiabetesLWBWNCT00770926
Reducing Disparities in Diabetes Risk Through Lifestyle Changes in Community Settings
A study testing Live Well, Be Well in people with Diabetes, run by University of California, San Francisco at 1 site in United States.
Trial summary
This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on reaching lower-income, minority individuals. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Live Well, Be Well
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2013
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 25 and older
- moderate- to high-risk score on a Diabetes Risk Appraisal (DRA) (assessing sedentary behavior, family history of diabetes, race/ethnicity, gestational diabetes, hypertension, and high cholesterol) and a fasting fingerstick glucose level of 95-140 mg/dL (indicating high risk of diabetes).
- conversant in English or Spanish
Who cannot join
- diabetes, assessed by self-report of having ever been told by a physician that they have diabetes (other than gestational) OR use of an oral hypoglycemic medication or insulin, OR a fingerstick fasting glucose level of >150 mg/dl;
- unstable chronic or serious condition that could limit participation in unsupervised light to moderate physical activity (e.g. unstable angina, diagnosed with or hospitalized for chest pain, heart surgery, stroke, or myocardial infarction in the past 6 months);
- uncontrolled hypertension (systolic >180 mmHg or diastolic >105 mmHg);
- current pregnancy or attempting to conceive;
- plans to move from the area within 1 year;
- insufficient cognitive functioning to complete program procedures,
- implanted defibrillator,
- a hip or knee replacement in the past 3 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94118
About this study
Official title: Physical Activity and Diet to to Reduce Disparities in Diabetes Risk
This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on reaching lower-income, minority individuals.
Read the detailed description
To design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, to increase physical activity, decrease weight, and improve diet, offered in community-based settings to primarily lower income, minority persons aged 25 and older at moderate to high risk of diabetes. The design is a randomized controlled trial with the primary outcome being fasting plasma glucose; secondary outcomes are weight, physical activity, blood pressure, and other physiological risk factors as well as health-related quality of life. This project is a partnership between the University of California San Francisco and the City of Berkeley Division of Public Health.
- Conditions
- Diabetes
- Being tested
- Live Well, Be Well
- Keywords
- risk reduction, minority, diabetes prevention, lifestyle program, behavior change
- Medical subject headings
- Diabetes Mellitus, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Well, Be WellBehavioural
Lifestyle change program using personal contact and telephone counseling
| Study group | Role | What they receive |
|---|---|---|
| Program immediately | Experimental | Receives the lifestyle program as soon as possible after randomization Receives: Behavioral: Live Well, Be Well |
| Wait list control | No intervention | Wait one year and at the end of the year, is offered the option of participating in the program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured: one year
Secondary outcomes (1)
diet
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startSep 2006
- Primary completionAug 2009
- Study completionMay 2013
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 DiabetesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita L Stewart, Ph.D, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770926
- Sponsor's protocol ID
- R18DK067896-01A2
- Other IDs
- R18DK067896
- Acronym
- LWBW
- Status last verified
- May 2013
- First submitted
- 8 Oct 2008
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Delgadillo AT, Grossman M, Santoyo-Olsson J, Gallegos-Jackson E, Kanaya AM, Stewart AL. Description of an academic community partnership lifestyle program for lower income minority adults at risk for diabetes. Diabetes Educ. 2010 Jul-Aug;36(4):640-50. doi: 10.1177/0145721710374368. Epub 2010 Jun 24.
PubMed 20576836Santoyo-Olsson J, Cabrera J, Freyre R, Grossman M, Alvarez N, Mathur D, Guerrero M, Delgadillo AT, Kanaya AM, Stewart AL. An innovative multiphased strategy to recruit underserved adults into a randomized trial of a community-based diabetes risk reduction program. Gerontologist. 2011 Jun;51 Suppl 1(Suppl 1):S82-93. doi: 10.1093/geront/gnr026.
PubMed 21565823
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Diet to to Reduce Disparities in Diabetes Risk
- ClinicalTrials.gov ID
- NCT00770926
- Acronym / sponsor ID
- LWBW / R18DK067896-01A2
- Conditions
- Diabetes
- Keywords
- risk reduction, minority, diabetes prevention, lifestyle program, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 10 Oct 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.
This study aims to design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, in reducing risk of diabetes in persons at risk with a focus on reaching lower-income, minority individuals.
Detailed description
To design and test the effectiveness of a lifestyle diabetes risk reduction program, Live Well, Be Well, to increase physical activity, decrease weight, and improve diet, offered in community-based settings to primarily lower income, minority persons aged 25 and older at moderate to high risk of diabetes. The design is a randomized controlled trial with the primary outcome being fasting plasma glucose; secondary outcomes are weight, physical activity, blood pressure, and other physiological risk factors as well as health-related quality of life. This project is a partnership between the University of California San Francisco and the City of Berkeley Division of Public Health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program immediately | Experimental | Behavioral: Live Well, Be WellReceives the lifestyle program as soon as possible after randomization |
| Wait list control | No intervention | –Wait one year and at the end of the year, is offered the option of participating in the program |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 25 and older
- moderate- to high-risk score on a Diabetes Risk Appraisal (DRA) (assessing sedentary behavior, family history of diabetes, race/ethnicity, gestational diabetes, hypertension, and high cholesterol) and a fasting fingerstick glucose level of 95-140 mg/dL (indicating high risk of diabetes).
- conversant in English or Spanish
Key exclusion criteria (8 listed)
- diabetes, assessed by self-report of having ever been told by a physician that they have diabetes (other than gestational) OR use of an oral hypoglycemic medication or insulin, OR a fingerstick fasting glucose level of >150 mg/dl;
- unstable chronic or serious condition that could limit participation in unsupervised light to moderate physical activity (e.g. unstable angina, diagnosed with or hospitalized for chest pain, heart surgery, stroke, or myocardial infarction in the past 6 months);
- uncontrolled hypertension (systolic >180 mmHg or diastolic >105 mmHg);
- current pregnancy or attempting to conceive;
- plans to move from the area within 1 year;
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 |
|---|---|---|
| Live Well, Be WellLifestyle change program using personal contact and telephone counseling | Behavioural | Program immediately |
Primary outcome
Body weight
Time frame: one year
1 secondary outcome
diet
Time frame: One year
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 21 May 2013.
- Results publication: PubMed 20576836Delgadillo AT, Grossman M, Santoyo-Olsson J, Gallegos-Jackson E, Kanaya AM, Stewart AL. Description of an academic community partnership lifestyle program for lower income minority adults at risk for diabetes. Diabetes Educ. 2010 Jul-Aug;36(4):640-50. doi: 10.1177/0145721710374368. Epub 2010 Jun 24.
- Results publication: PubMed 21565823Santoyo-Olsson J, Cabrera J, Freyre R, Grossman M, Alvarez N, Mathur D, Guerrero M, Delgadillo AT, Kanaya AM, Stewart AL. An innovative multiphased strategy to recruit underserved adults into a randomized trial of a community-based diabetes risk reduction program. Gerontologist. 2011 Jun;51 Suppl 1(Suppl 1):S82-93. doi: 10.1093/geront/gnr026.
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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.
Anita L Stewart, Ph.D principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live Well, Be Well in people with Diabetes, run by University of California, San Francisco 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 8 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 21 May 2013. 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.
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?
Body weight (time frame: one year). 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 NCT00770926, 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 21 May 2013.