Metabolic SyndromeLLDPPNCT00810290
Lawrence Latino Diabetes Prevention Project
A study testing lifestyle intervention in people with Metabolic Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a >30% probability of developing diabetes in the next 7.5 years per a predictive equation. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jul 2008
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is Latino/Hispanic;
- Has a 7.5 year likelihood of becoming diabetic of greater than or equal to 30% as predicted by the Stern formula;
- Is greater than or equal to 25 years of age;
- Has a BMI greater than or equal to 24 kg m2.
Who cannot join
- An inability or unwillingness to give informed consent;
- Has clinically diagnosed diabetes, or a fasting blood sugar of greater than or equal to 126 mg/dl;
- Plans to move out of the area within the study period;
- Has a psychiatric illness which limits ability to participate;
- Has no telephone;
- Is unable to walk unaided, or cannot walk five city blocks (1/4 mile) without stopping;
Show all 9Show fewer
- Is not cleared for the PA component by the pt's GLFHC primary care provider;
- Has a medical conditions likely to limit lifespan;
- Is on medications or has a medical condition that interfere with the assessment for diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lawrence Senior Center
Lawrence, Massachusetts, 01840
About this study
The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a >30% probability of developing diabetes in the next 7.5 years per a predictive equation. The project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban Latino community. Individuals were identified primarily from a community health center's patient panel, screened for study eligibility, randomized to either a usual care or a lifestyle intervention condition, and followed for one year.
Read the detailed description
The group format of the intervention included 13 group sessions complemented by 3 individual home contacts over one year and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist. Study measures included demographics, Stern predictive equation components (age, gender, ethnicity, fasting glucose, systolic blood pressure, HDL-cholesterol, body mass index, and family history of diabetes), glycosylated hemoglobin, dietary intake, physical activity, depressive symptoms, social support, and quality of life. Body weight was measured at baseline, 6-months, and one-year; all other measures were assessed at baseline and one-year. All surveys were orally administered in Spanish.
- Conditions
- Metabolic Syndrome
- Being tested
- lifestyle intervention
- Keywords
- Metabolic syndrome, Latino health, Community participatory research, Translational Research
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionBehavioural
A group-based intervention including 13 group sessions complemented by three individual home visits was developed using principles of social learning theory and patient-centered counseling. The intervention was intended to increase awareness of diabetes prevention strategies, foster positive diabetes prevention attitudes (i.e., self-efficacy) and promote healthy lifestyle behaviors in the target Latino population using literacy-sensitive and culturally-tailored strategies and materials.
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss.
Measured: 1 year
HgbA1c
Measured: 1 year
Secondary outcomes (5)
Change in fasting blood sugar.
Measured: 1 year
Changes in LDL- and HDL-cholesterol.
Measured: 1 year
Change in blood pressure.
Measured: 1 year
Change in depression.
Measured: 1 year
Change in quality of life.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJul 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Ira S Ockene, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810290
- Sponsor's protocol ID
- H-11214
- Other IDs
- DK67549
- Acronym
- LLDPP
- Status last verified
- Feb 2010
- First submitted
- 17 Dec 2008
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Olendzki BC, Ma Y, Hebert JR, Pagoto SL, Merriam PA, Rosal MC, Ockene IS. Underreporting of energy intake and associated factors in a Latino population at risk of developing type 2 diabetes. J Am Diet Assoc. 2008 Jun;108(6):1003-8. doi: 10.1016/j.jada.2008.03.006.
PubMed 18502234Ockene IS, Tellez TL, Rosal MC, Reed GW, Mordes J, Merriam PA, Olendzki BC, Handelman G, Nicolosi R, Ma Y. Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project. Am J Public Health. 2012 Feb;102(2):336-42. doi: 10.2105/AJPH.2011.300357. Epub 2011 Dec 15.
PubMed 22390448Merriam PA, Tellez TL, Rosal MC, Olendzki BC, Ma Y, Pagoto SL, Ockene IS. Methodology of a diabetes prevention translational research project utilizing a community-academic partnership for implementation in an underserved Latino community. BMC Med Res Methodol. 2009 Mar 13;9:20. doi: 10.1186/1471-2288-9-20.
PubMed 19284663
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lawrence Latino Diabetes Prevention Project
- ClinicalTrials.gov ID
- NCT00810290
- Acronym / sponsor ID
- LLDPP / H-11214
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic syndrome, Latino health, Community participatory research, Translational Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jul 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 Dec 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 Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a >30% probability of developing diabetes in the next 7.5 years per a predictive equation. The project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban Latino community. Individuals were identified primarily from a community health center's patient panel, screened for study eligibility, randomized to either a usual care or a lifestyle intervention condition, and followed for one year.
Detailed description
The group format of the intervention included 13 group sessions complemented by 3 individual home contacts over one year and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist. Study measures included demographics, Stern predictive equation components (age, gender, ethnicity, fasting glucose, systolic blood pressure, HDL-cholesterol, body mass index, and family history of diabetes), glycosylated hemoglobin, dietary intake, physical activity, depressive symptoms, social support, and quality of life. Body weight was measured at baseline, 6-months, and one-year; all other measures were assessed at baseline and one-year. All surveys were orally administered in Spanish.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Is Latino/Hispanic;
- Has a 7.5 year likelihood of becoming diabetic of greater than or equal to 30% as predicted by the Stern formula;
- Is greater than or equal to 25 years of age;
- Has a BMI greater than or equal to 24 kg m2.
Key exclusion criteria (9 listed)
- An inability or unwillingness to give informed consent;
- Has clinically diagnosed diabetes, or a fasting blood sugar of greater than or equal to 126 mg/dl;
- Plans to move out of the area within the study period;
- Has a psychiatric illness which limits ability to participate;
- Has no telephone;
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 |
|---|---|---|
| lifestyle interventionA group-based intervention including 13 group sessions complemented by three individual home visits was developed using principles of social learning theory and patient-centered counseling. The intervention was intended to increase awareness of diabetes prevention strategies, foster positive diabetes prevention attitudes (i.e., self-efficacy) and promote healthy lifestyle behaviors in the target Latino population using literacy-sensitive and culturally-tailored strategies and materials. | Behavioural | – |
Primary outcome
Weight loss.
Time frame: 1 year
HgbA1c
Time frame: 1 year
5 secondary outcomes
Change in fasting blood sugar.
Time frame: 1 year
Changes in LDL- and HDL-cholesterol.
Time frame: 1 year
Change in blood pressure.
Time frame: 1 year
Change in depression.
Time frame: 1 year
Change in quality of life.
Time frame: 1 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 8 Feb 2010.
- Background: PubMed 18502234Olendzki BC, Ma Y, Hebert JR, Pagoto SL, Merriam PA, Rosal MC, Ockene IS. Underreporting of energy intake and associated factors in a Latino population at risk of developing type 2 diabetes. J Am Diet Assoc. 2008 Jun;108(6):1003-8. doi: 10.1016/j.jada.2008.03.006.
- Derived from this study: PubMed 22390448Ockene IS, Tellez TL, Rosal MC, Reed GW, Mordes J, Merriam PA, Olendzki BC, Handelman G, Nicolosi R, Ma Y. Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project. Am J Public Health. 2012 Feb;102(2):336-42. doi: 10.2105/AJPH.2011.300357. Epub 2011 Dec 15.
- Derived from this study: PubMed 19284663Merriam PA, Tellez TL, Rosal MC, Olendzki BC, Ma Y, Pagoto SL, Ockene IS. Methodology of a diabetes prevention translational research project utilizing a community-academic partnership for implementation in an underserved Latino community. BMC Med Res Methodol. 2009 Mar 13;9:20. doi: 10.1186/1471-2288-9-20.
Related trials for Metabolic Syndrome
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
RecruitingPhase 3
A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight
Sleep Apnea, Obstructive, Obesity
Recruiting
Our Voices Matter: Intervention for Depression in Youth
Depressive Symptoms, Allostatic Load
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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.
Ira S Ockene, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lifestyle intervention in people with Metabolic Syndrome, run by University of Massachusetts, Worcester 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 4 inclusion and 9 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 8 Feb 2010. 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?
Weight loss. (time frame: 1 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 NCT00810290, which also lists 3 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 8 Feb 2010.