Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care

Obesity Clinical Trial

— E-LITE  

Official title:

A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842426
• Other study ID #: R34DK080878
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2009
• Last updated: September 11, 2012
• Start date: June 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2012
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 diabetes and cardiovascular disease.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Pre-diabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation, Los Altos Center	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	American Heart Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		Baseline, 3-, 6- and 15- month follow-up	No
Secondary	Metabolic syndrome criterion factors: waist circumference, BP, FBG, TG, HDL, TG/HDL		Baseline, 6-, and 15-months	No
Secondary	A1C, C-reactive protein		Baseline and 15-months	No
Secondary	Dietary Intake		Baseline, 3-, 6-, and 15-months	No
Secondary	Physical Activity		Baseline, 3-, 6-, and 15-months	No
Secondary	Generic and Obesity-specific Health Related Quality of Life		Baseline, 3-, 6-, and 15-months	No
Secondary	Patient and Physician Satisfaction		Baseline, 3-, 6-, and 15-months	No