Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care (E-LITE)

September 11, 2012 updated by: Jun Ma, MD, PhD, Palo Alto Medical Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94022
        • Palo Alto Medical Foundation, Los Altos Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Experimental: Self-Management Program
Online Self-Management.
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 Names:
  • 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 Names:
  • Intensive Lifestyle Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body Mass Index
Time Frame: Baseline, 3-, 6- and 15- month follow-up
Baseline, 3-, 6- and 15- month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Metabolic syndrome criterion factors: waist circumference, BP, FBG, TG, HDL, TG/HDL
Time Frame: Baseline, 6-, and 15-months
Baseline, 6-, and 15-months
A1C, C-reactive protein
Time Frame: Baseline and 15-months
Baseline and 15-months
Dietary Intake
Time Frame: Baseline, 3-, 6-, and 15-months
Baseline, 3-, 6-, and 15-months
Physical Activity
Time Frame: Baseline, 3-, 6-, and 15-months
Baseline, 3-, 6-, and 15-months
Generic and Obesity-specific Health Related Quality of Life
Time Frame: Baseline, 3-, 6-, and 15-months
Baseline, 3-, 6-, and 15-months
Patient and Physician Satisfaction
Time Frame: Baseline, 3-, 6-, and 15-months
Baseline, 3-, 6-, and 15-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Medical Foundation

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Heart Association

Investigators

  • Principal Investigator: Jun Ma, M.D., Ph.D., Palo Alto Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

September 13, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34DK080878 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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