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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842426
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : September 13, 2012
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Heart Association
Information provided by (Responsible Party):
Jun Ma, MD, PhD, Palo Alto Medical Foundation

Tracking Information
First Submitted Date  ICMJE February 11, 2009
First Posted Date  ICMJE February 12, 2009
Last Update Posted Date September 13, 2012
Study Start Date  ICMJE June 2009
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
Body Mass Index [ Time Frame: Baseline, 3-, 6- and 15- month follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
Body Mass Index [ Time Frame: Baseline, 2-, 6- and 12- month follow-up ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2009)
  • Metabolic syndrome criterion factors: waist circumference, BP, FBG, TG, HDL, TG/HDL [ Time Frame: Baseline, 6-, and 12-months ]
  • A1C [ Time Frame: Baseline, 6-, and 12-months ]
  • Dietary Intake [ Time Frame: Baseline, 2-, 6-, and 12-months ]
  • Physical Activity [ Time Frame: Baseline, 2-, 6-, and 12-months ]
  • Health Related Quality of Life [ Time Frame: Baseline, 2-, 6-, and 12-months ]
  • Patient and Physician Satisfaction [ Time Frame: Baseline, 2-, 6-, and 12-months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care
Official Title  ICMJE A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Obesity
  • Pre-diabetes
  • Metabolic Syndrome
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • No Intervention: Usual Care
    Usual Care
  • Experimental: Self-Management Program
    Online Self-Management.
    Intervention: Behavioral: Self-management program (SM)
  • 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.
    Intervention: Behavioral: Care management program (CM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2012)
241
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2009)
240
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00842426
Other Study ID Numbers  ICMJE R34DK080878( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jun Ma, MD, PhD, Palo Alto Medical Foundation
Study Sponsor  ICMJE Palo Alto Medical Foundation
Collaborators  ICMJE
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • American Heart Association
Investigators  ICMJE
Principal Investigator: Jun Ma, M.D., Ph.D. Palo Alto Medical Foundation
PRS Account Palo Alto Medical Foundation
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP