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

Phase 2

Completed

• Conditions: Obesity; Pre-diabetes; Metabolic Syndrome
• Interventions: Behavioral: Self-management program (SM); Behavioral: Care management program (CM)

• Registration Number: NCT00842426
• Lead Sponsor: Palo Alto Medical Foundation

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 Timeline

• Study First Submitted: 2009-02-11
• Study First Submitted QC: 2009-02-11
• Study First Posted: 2009-02-12
• Study Start: 2009-06
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Management Program	Self-management program (SM)	Online Self-Management.
Care Management Program	Care management program (CM)	Care management lifestyle modification program with intensive intervention phase with exercise and nutrition specialist. Followed by a online self-management phase.

Primary Outcome Measures

Name	Time	Method
Body Mass Index	Baseline, 3-, 6- and 15- month follow-up

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Palo Alto Medical Foundation, Los Altos Center; 🇺🇸 Palo Alto, California, United States