Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE)
|ClinicalTrials.gov Identifier: NCT00842426|
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : September 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity Pre-diabetes Metabolic Syndrome||Behavioral: Self-management program (SM) Behavioral: Care management program (CM)||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
No Intervention: Usual Care
Experimental: Self-Management Program
Behavioral: Self-management program (SM)
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.
Other Name: Self-monitoring and online tracking
Experimental: Care Management Program
Care management lifestyle modification program with intensive intervention phase with exercise and nutrition specialist. Followed by a online self-management phase.
Behavioral: Care management program (CM)
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.
Other Name: Intensive Lifestyle Program
- Body Mass Index [ Time Frame: Baseline, 3-, 6- and 15- month follow-up ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842426
|United States, California|
|Palo Alto Medical Foundation, Los Altos Center|
|Palo Alto, California, United States, 94022|
|Principal Investigator:||Jun Ma, M.D., Ph.D.||Palo Alto Medical Foundation|