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

Completed · Phase 2

Conditions studied: Obesity, Pre-diabetes, Metabolic Syndrome

In brief

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.

Key facts

Study ID: NCT00842426
Run by: Palo Alto Medical Foundation
People needed: 241
Starts: 2009-06-01
Expected to finish: 2011-10-01
Last updated by the study team: 2012-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Palo Alto Medical Foundation, Los Altos Center — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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