Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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.


Options:
A: Inclusion Criteria:

* Adults age 20-55 inclusive
* BMI between 25 and 35 inclusive (overweight and Class 1 obese subjects)
* PC Computer with an available USB port, speakers and high-speed internet access in a secure setting (home or private office)
* Fluency in English (spoken and written)
* Have a Primary Care Physician
* Answer "No" to all 7 questions on PAR-Q OR have letter from PCP clearing them to take part in study

Exclusion Criteria:

* Disability, medical or surgical condition preventing or precluding moderate physical activity.
* Cognitive impairment.
B: 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.
C: Inclusion Criteria:

* 18-65 years older men \& women
* Body mass index 25.0-39.9
* Ability to provide informed consent

Exclusion Criteria:

* Type I Diabetes
* Type II diabetes taking insulin
* Surgery or Hospitalization in last year (unless minor outpatient surgery)
* Blood pressure \>159/94
* Cancer (other than non-melanoma skin cancer) in last 5 years
* History of bariatric surgery
* Current treatment with herbal, over-the-counter, or prescription weight loss drugs
* Current treatment with ant-metabolite medications or other medications that affect weight
* Current pregnancy or breastfeeding, or plans pregnancy in next 18 months gastrointestinal disorders including ulcerative colitis, Crohn's disease, malabsorption syndromes)
* Chronic renal insufficiency
* Chronic liver disease
* History of anorexia nervosa, bulimia, laxative abuse
* Current alcohol or substance abuse
* Chronic heart failure, New York Heart Association Class III or IV
* Uncontrolled arrythmia
* Uncontrolled hyper- or hypothyroidism
* Large weight loss of 20 or more kilograms in the past year
* Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness
* Center for Epidemiologic Studies Depression Scale Score ≥ 16
* Musculoskeletal problems interfering with exercise.
* Autoimmune or collagen vascular diseases.
* Immunodeficiency diseases or a positive Human immunodeficiency virus test
* Unable to give informed consent
D: Inclusion Criteria:

* be between the ages of 18-60 years old
* be a non-smoker
* live in the Chapel Hill, NC area
* be able to attend monitoring visits at baseline, 3-months, and 6-months
* have access to the Internet and a computer
* have access to an Internet-capable mobile device (such as an iPhone, iPod Touch, or Blackberry) and an MP3 player (this may be the same device)
* have access to a scale for self-monitoring weight
* be willing to be randomized to either group
* be free of psychiatric diseases, drug or alcohol dependency, or uncontrolled thyroid conditions
* be free of major health conditions, such as heart conditions, diabetes, and past incidence of stroke
* have MD consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues.
* able to prepare all their own meals (i.e. not living on-campus)

Exclusion Criteria:

* should not be pregnant, anticipating on becoming pregnant in the next 7 months, or currently breastfeeding
* be free of an eating disorder as screened by the Eating disorder Screen for Primary care \[ESP\].
* no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own)
* have not participated in previous podcasting weight loss research

Answer: B