ObesityPhase 2E-LITENCT00842426
Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care
A Phase 2 study testing Self-management program (SM) and Care management program (CM) in people with Obesity and Pre-diabetes, run by Palo Alto Medical Foundation at 1 site in United States.
Trial summary
The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Pre-diabetes, Metabolic Syndrome
- What is being tested?
- Self-management program (SM) and Care management program (CM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnicity: All ethnic groups;
- Body mass index 25.0-39.9 kg/m2;
- Fasting plasma glucose between 100 and 125 mg/dL;
- Any two of the following: Waist circumference >40 inches in men, >35 inches in women (if in Asian American ≥ 35 inches in men; ≥31 inches in women); Triglycerides >150 mg/dL; High-density lipoprotein cholesterol (HDL-C) <40 mg/dL in men, <50 mg/dL in women; Systolic blood pressure >130 mm Hg or diastolic blood pressure >85 mm Hg.
- Having a primary care physician (PCP) at the PAMF Los Altos Center;
- Seen in primary or specialty care in the Palo Alto Region at least once in the preceding 24 months;
- A PAMF patient for ≥ 12 months;
- Able and willing to enroll and meet the requirements of the study.
Who cannot join
- Inability to speak, read or understand English;
- No regular access to a computer with Internet and email capabilities;
- Triglycerides >400 mg/dL;
- Systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg;
- Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months
- Having a medical (e.g., celiac disease) or social condition (e.g., religious beliefs) that precludes dietary changes;
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- Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe;
- Use of weight-loss medications in the past 3 months;
- Regular use (> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.);
- Currently enrolled in a lifestyle intervention program at PAMF or elsewhere;
- Planning to undergo a bariatric surgery during the study period;
- Diagnosis of Type 1 or Type 2 diabetes mellitus;
- Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, renal, liver), heart disease, stroke, and ongoing substance abuse;
- Renal insufficiency (i.e., GFR < 60 mL/min/1.73m2)
- Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
- Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
- Diagnosis of a terminal illness and/or in hospice care;
- Pregnant, lactating or planning to become pregnant during the study period;
- Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings;
- Family/household member of another study participant or of a study staff member;
- No longer a PAMF patient or planning to transfer care outside of PAMF during the study period;
- Planning to move out of the area during the study period;
- PCP determination that the study is inappropriate or unsafe for the patient;
- Investigator discretion for clinical safety or protocol adherence reasons.
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation, Los Altos Center
Palo Alto, California, 94022
About this study
Official title: A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics
The purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for diabetes and cardiovascular disease.
Read the detailed description
In the United States, there is an epidemic of obesity and, as a result, an epidemic of diabetes. Obese individuals with pre-diabetes (defined as impaired fasting glucose or impaired glucose tolerance) are at high risk for progression to diabetes. A vast majority of these individuals also have an increased risk of cardiovascular disease because of concomitant risk factors, such as abdominal obesity, dyslipidemia, and elevated blood pressure. Intensive lifestyle interventions that focus on dietary change, physical activity, and behavior modification have demonstrated efficacy in achieving and maintaining clinically significant (>5%) weight loss in populations of patients with pre-diabetes. However, the effectiveness, cost-effectiveness, generalizability, and sustainability of such interventions in routine primary care settings remain unknown, and rigorous clinical research is needed.
The primary hypothesis for the E-LITE Study is that the CM intervention will reduce BMI more than the SM intervention, which in turn will reduce BMI more than usual care, over 15 months. Secondarily, we hypothesize that, compared with usual care, intervention participants will be associated with greater improvements in waist circumference, lipids, blood pressure, blood glucose, lifestyle behaviors, and psychosocial well-being. In addition, we will examine the durability of weight loss and behavioral change in the months after the initial 3-month intensive stage.
- Conditions
- Obesity, Pre-diabetes, Metabolic Syndrome
- Being tested
- Self-management program (SM), Care management program (CM)
- Keywords
- Diabetes, Cardiovascular disease, Metabolic syndrome, Cardiometabolic
- Medical subject headings
- Obesity, Glucose Intolerance, Metabolic Syndrome, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management program (SM)Behavioural
Also called Self-monitoring and online tracking
Participants will attend a group orientation where the study nutritionist will provide an overview of the self-management lifestyle intervention program. Participants will receive instructions on how to use HeartHubTM, the American Heart Association's patient portal for information, tools, resources about cardiovascular risk assessment, goal setting, action planning, and self-monitoring.
During the remainder of the 15-month intervention, participants will receive reminders on a regular basis to use the patient portal to assist in their ongoing self-management.
Care management program (CM)Behavioural
Also called Intensive Lifestyle Program
In addition to participating in the activities described above, with the exception of the orientation session, participants in the Care Management Program will attend 12 weekly weight management classes during the initial 3 months. Classes will be co-led by a dietician and exercise specialist and will include a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by individual action-planning and goal-setting.
During the remainder of the 15-month intervention, participants will continue to monitor their body weight, caloric intake, physical activity, and other data according to their care plan. In addition, study interventionist will follow up with participants regularly, via secure messaging or by phone, to provide ongoing counseling and support.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Usual Care |
| Self-Management Program | Experimental | Online Self-Management. Receives: Behavioral: Self-management program (SM) |
| Care Management Program | Experimental | Care management lifestyle modification program with intensive intervention phase with exercise and nutrition specialist. Followed by a online self-management phase. Receives: Behavioral: Care management program (CM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Measured: Baseline, 3-, 6- and 15- month follow-up
Secondary outcomes (6)
Metabolic syndrome criterion factors: waist circumference, BP, FBG, TG, HDL, TG/HDL
Measured: Baseline, 6-, and 15-months
A1C, C-reactive protein
Measured: Baseline and 15-months
Dietary Intake
Measured: Baseline, 3-, 6-, and 15-months
Physical Activity
Measured: Baseline, 3-, 6-, and 15-months
Generic and Obesity-specific Health Related Quality of Life
Measured: Baseline, 3-, 6-, and 15-months
Patient and Physician Satisfaction
Measured: Baseline, 3-, 6-, and 15-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Heart Association
- Responsible party
- Principal investigator, Jun Ma, MD, PhD, Palo Alto Medical Foundation
- Investigators
- Jun Ma, M.D., Ph.D., Principal investigator, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842426
- Sponsor's protocol ID
- R34DK080878
- Acronym
- E-LITE
- Status last verified
- Sep 2012
- First submitted
- 11 Feb 2009
- Last updated
- 13 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiao L, Lv N, Rosas LG, Au D, Ma J. Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials. Obesity (Silver Spring). 2017 Feb;25(2):363-369. doi: 10.1002/oby.21737. Epub 2017 Jan 6.
PubMed 28059466Azar KM, Xiao L, Ma J. Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care. Biomed Res Int. 2013;2013:191209. doi: 10.1155/2013/191209. Epub 2013 Dec 4.
PubMed 24369008Ma J, Yank V, Xiao L, Lavori PW, Wilson SR, Rosas LG, Stafford RS. Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA Intern Med. 2013 Jan 28;173(2):113-21. doi: 10.1001/2013.jamainternmed.987.
PubMed 23229846Yank V, Stafford RS, Rosas LG, Ma J. Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: a structured report of real-world applicability. Contemp Clin Trials. 2013 Jan;34(1):126-35. doi: 10.1016/j.cct.2012.10.007. Epub 2012 Oct 31.
PubMed 23124047Ma J, King AC, Wilson SR, Xiao L, Stafford RS. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial. BMC Fam Pract. 2009 Nov 12;10:71. doi: 10.1186/1471-2296-10-71.
PubMed 19909549
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics
- ClinicalTrials.gov ID
- NCT00842426
- Acronym / sponsor ID
- E-LITE / R34DK080878
- Conditions
- Obesity, Pre-diabetes, Metabolic Syndrome
- Keywords
- Diabetes, Cardiovascular disease, Metabolic syndrome, Cardiometabolic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Heart Association
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Feb 2009 (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 purpose of the E-LITE Study is to evaluate the feasibility and potential effectiveness of two lifestyle interventions in a community based primary care setting. The study aims to assess how changes in diet, exercise, and behavioral self-management affect weight and related risk factors for adults at risk for diabetes and cardiovascular disease.
Detailed description
In the United States, there is an epidemic of obesity and, as a result, an epidemic of diabetes. Obese individuals with pre-diabetes (defined as impaired fasting glucose or impaired glucose tolerance) are at high risk for progression to diabetes. A vast majority of these individuals also have an increased risk of cardiovascular disease because of concomitant risk factors, such as abdominal obesity, dyslipidemia, and elevated blood pressure. Intensive lifestyle interventions that focus on dietary change, physical activity, and behavior modification have demonstrated efficacy in achieving and maintaining clinically significant (>5%) weight loss in populations of patients with pre-diabetes. However, the effectiveness, cost-effectiveness, generalizability, and sustainability of such interventions in routine primary care settings remain unknown, and rigorous clinical research is needed.
The primary hypothesis for the E-LITE Study is that the CM intervention will reduce BMI more than the SM intervention, which in turn will reduce BMI more than usual care, over 15 months. Secondarily, we hypothesize that, compared with usual care, intervention participants will be associated with greater improvements in waist circumference, lipids, blood pressure, blood glucose, lifestyle behaviors, and psychosocial well-being. In addition, we will examine the durability of weight loss and behavioral change in the months after the initial 3-month intensive stage.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Usual Care |
| Self-Management Program | Experimental | Behavioral: Self-management program (SM)Online Self-Management. |
| Care Management Program | Experimental | Behavioral: Care management program (CM)Care management lifestyle modification program with intensive intervention phase with exercise and nutrition specialist. Followed by a online self-management phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ethnicity: All ethnic groups;
- Body mass index 25.0-39.9 kg/m2;
- Fasting plasma glucose between 100 and 125 mg/dL;
- Any two of the following: Waist circumference >40 inches in men, >35 inches in women (if in Asian American ≥ 35 inches in men; ≥31 inches in women); Triglycerides >150 mg/dL; High-density lipoprotein cholesterol (HDL-C) <40 mg/dL in men, <50 mg/dL in women; Systolic blood pressure >130 mm Hg or diastolic blood pressure >85 mm Hg.
- Having a primary care physician (PCP) at the PAMF Los Altos Center;
Key exclusion criteria (24 listed)
- Inability to speak, read or understand English;
- No regular access to a computer with Internet and email capabilities;
- Triglycerides >400 mg/dL;
- Systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg;
- Initiation or change of drug therapy for elevated blood pressure or abnormal lipid levels within the past 3 months
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 |
|---|---|---|
| Self-management program (SM)Also: Self-monitoring and online trackingParticipants will attend a group orientation where the study nutritionist will provide an overview of the self-management lifestyle intervention program. Participants will receive instructions on how to use HeartHubTM, the American Heart Association's patient portal for information, tools, resources about cardiovascular risk assessment, goal setting, action planning, and self-monitoring. During the remainder of the 15-month intervention, participants will receive reminders on a regular basis to use the patient portal to assist in their ongoing self-management. | Behavioural | Self-Management Program |
| Care management program (CM)Also: Intensive Lifestyle ProgramIn addition to participating in the activities described above, with the exception of the orientation session, participants in the Care Management Program will attend 12 weekly weight management classes during the initial 3 months. Classes will be co-led by a dietician and exercise specialist and will include a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by individual action-planning and goal-setting. During the remainder of the 15-month intervention, participants will continue to monitor their body weight, caloric intake, physical activity, and other data according to their care plan. In addition, study interventionist will follow up with participants regularly, via secure messaging or by phone, to provide ongoing counseling and support. | Behavioural | Care Management Program |
Primary outcome
Body Mass Index
Time frame: Baseline, 3-, 6- and 15- month follow-up
6 secondary outcomes
Metabolic syndrome criterion factors: waist circumference, BP, FBG, TG, HDL, TG/HDL
Time frame: Baseline, 6-, and 15-months
A1C, C-reactive protein
Time frame: Baseline and 15-months
Dietary Intake
Time frame: Baseline, 3-, 6-, and 15-months
Physical Activity
Time frame: Baseline, 3-, 6-, and 15-months
Generic and Obesity-specific Health Related Quality of Life
Time frame: Baseline, 3-, 6-, and 15-months
Patient and Physician Satisfaction
Time frame: Baseline, 3-, 6-, and 15-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 13 Sep 2012.
- Derived from this study: PubMed 28059466Xiao L, Lv N, Rosas LG, Au D, Ma J. Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials. Obesity (Silver Spring). 2017 Feb;25(2):363-369. doi: 10.1002/oby.21737. Epub 2017 Jan 6.
- Derived from this study: PubMed 24369008Azar KM, Xiao L, Ma J. Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care. Biomed Res Int. 2013;2013:191209. doi: 10.1155/2013/191209. Epub 2013 Dec 4.
- Derived from this study: PubMed 23229846Ma J, Yank V, Xiao L, Lavori PW, Wilson SR, Rosas LG, Stafford RS. Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA Intern Med. 2013 Jan 28;173(2):113-21. doi: 10.1001/2013.jamainternmed.987.
- Derived from this study: PubMed 23124047Yank V, Stafford RS, Rosas LG, Ma J. Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: a structured report of real-world applicability. Contemp Clin Trials. 2013 Jan;34(1):126-35. doi: 10.1016/j.cct.2012.10.007. Epub 2012 Oct 31.
- Derived from this study: PubMed 19909549Ma J, King AC, Wilson SR, Xiao L, Stafford RS. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial. BMC Fam Pract. 2009 Nov 12;10:71. doi: 10.1186/1471-2296-10-71.
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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.
Jun Ma, M.D., Ph.D. principal investigator
Palo Alto Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Self-management program (SM) and Care management program (CM) in people with Obesity and Pre-diabetes, run by Palo Alto Medical Foundation 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 8 inclusion and 24 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 13 Sep 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mass Index (time frame: Baseline, 3-, 6- and 15- month follow-up). 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 NCT00842426, which also lists 5 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 13 Sep 2012.