Clinical trial NCT00842426: Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care
Official title: A Pilot of Customized Continuous Care Management of Obesity in Pre-Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Pre-diabetes
Metabolic Syndrome
Keywords: Diabetes
Cardiovascular disease
Metabolic syndrome
Cardiometabolic
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: American Heart Association
First posted: 2009-02-12
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 3-, 6- and 15- month follow-up
Secondary outcomes:
measure: Metabolic syndrome criterion factors: waist circumference, BP, FBG, TG, HDL, TG/HDL
timeFrame: Baseline, 6-, and 15-months
measure: A1C, C-reactive protein
timeFrame: Baseline and 15-months
measure: Dietary Intake
timeFrame: Baseline, 3-, 6-, and 15-months
measure: Physical Activity
timeFrame: Baseline, 3-, 6-, and 15-months
measure: Generic and Obesity-specific Health Related Quality of Life
timeFrame: Baseline, 3-, 6-, and 15-months
measure: Patient and Physician Satisfaction
timeFrame: Baseline, 3-, 6-, and 15-months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation, Los Altos Center
state: California
Study officials:
affiliation: Palo Alto Medical Foundation
name: Jun Ma, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xiao L, Lv N, Rosas LG, Au D, Ma J. Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials. Obesity (Silver Spring). 2017 Feb;25(2):363-369. doi: 10.1002/oby.21737. Epub 2017 Jan 6.
citation: Azar KM, Xiao L, Ma J. Baseline obesity status modifies effectiveness of adapted diabetes prevention program lifestyle interventions for weight management in primary care. Biomed Res Int. 2013;2013:191209. doi: 10.1155/2013/191209. Epub 2013 Dec 4.
citation: Ma J, Yank V, Xiao L, Lavori PW, Wilson SR, Rosas LG, Stafford RS. Translating the Diabetes Prevention Program lifestyle intervention for weight loss into primary care: a randomized trial. JAMA Intern Med. 2013 Jan 28;173(2):113-21. doi: 10.1001/2013.jamainternmed.987.
citation: Yank V, Stafford RS, Rosas LG, Ma J. Baseline reach and adoption characteristics in a randomized controlled trial of two weight loss interventions translated into primary care: a structured report of real-world applicability. Contemp Clin Trials. 2013 Jan;34(1):126-35. doi: 10.1016/j.cct.2012.10.007. Epub 2012 Oct 31.
citation: Ma J, King AC, Wilson SR, Xiao L, Stafford RS. Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial. BMC Fam Pract. 2009 Nov 12;10:71. doi: 10.1186/1471-2296-10-71.