A Phase 2 interventional study of Self-management program (SM) and Care management program (CM) in Obesity, Pre-diabetes and Metabolic Syndrome, sponsored by Palo Alto Medical Foundation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-13.
Sponsored by Palo Alto Medical Foundation · Phase 2, Interventional, and Health services research
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.
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 241 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Palo Alto Medical Foundation is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Usual Care
Online Self-Management.
Behavioral: Self-management program (SM)
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)
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.
Also known as: Self-monitoring and online tracking
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.
Also known as: 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
This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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Palo Alto Medical Foundation