Status:
COMPLETED
Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care
Lead Sponsor:
Palo Alto Medical Foundation
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Heart Association
Conditions:
Obesity
Pre-diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 change...
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT00842426
Start Date
June 1 2009
End Date
October 1 2011
Last Update
September 13 2012
Active Locations (1)
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1
Palo Alto Medical Foundation, Los Altos Center
Palo Alto, California, United States, 94022