Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feasibility of a Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males
Brief Summary: The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response biomarker.


Options:
A: Inclusion Criteria:

* Age 18 to 35 years
* Intending to be available for a 24 month intervention
* Full-time student enrollment at one of the designated San Diego college or university campuses: UCSD, SDSU, and CSU San Marcos
* Facebook user or willingness to begin using Facebook
* Owns personal computer
* Owns mobile phone and uses text messaging
* Willing to attend required research measurement visits in San Diego over the 2 year RCT
* Participants must meet overweight and obesity criteria: 25 \< BMI \<35 kg/m2
* English-speaking
* Able to ambulate unassisted

Exclusion Criteria:

* Those unable to provide informed consent
* Those with a BMI of \<25 kg/m2 or \>35 kg/m2
* Those who have a household member on the study staff
* Those with any comorbidities of obesity who require immediate sub-specialist referral including pseudo-tumor cerebri, sleep apnea/hypoventilation syndrome, orthopedic problems, and meeting American Diabetes Association criteria for diabetes
* Cardiovascular event within the last 6 months
* Systolic BP at screening of \>160 mmHg OR diastolic BP \> 100 mmHg
* Current treatment for malignancy other than non-melanoma skin cancer
* Psychiatric or medical condition that prohibit compliance with study protocol, prescribed dietary changes and/or moderate physical activity
* Current treatment for eating disorder
* Taking medications that alter weight
* Regular use of systemic steroids
* Currently pregnant, gave birth within the last 6 months, currently lactating or breastfeeding within the last 3 months or intending to get pregnant over the next two years
* Enrolled in or planning to enroll in another weight loss program
* Past or planned (within the next 24 months) weight loss surgery
* Current participation in a commercial weight loss program
* Investigator discretion
* Non-English speaking
* Not able to ambulate unassisted
B: Inclusion Criteria:

* 18-64 years of age
* BMI between 25 to 45.0 kg/m² (NOTE: The investigators elected to cap this at 45.0 kg/m² to minimize potential risks and to reduce the potential for obesity to limit exercise participation)
* Ability to provide informed consent and health risk assessment prior to participation in this study
* Speak, read, and write either English and/or Spanish

Exclusion Criteria:

* Uncontrolled diabetes mellitus
* History of bariatric surgery
* Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
* Current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
* Resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥90 mmHg
* Eating disorders that would contraindicate weight loss or physical activity
* Alcohol or substance abuse
* Currently treated for psychological issues (i.e. depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
* Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
* Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
* Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments
C: Inclusion Criteria:

* desire to lose weight;
* agree to attend visits per protocol;
* access to telephone and transportation;
* English speaking;
* able to complete study measures;
* smart phone with data and texting plan;
* body mass index 30 kg/m2 or greater

Exclusion Criteria:

* pregnancy, breastfeeding, or lack of birth control if premenopausal
* dementia, excessive alcohol use, or psychiatric illness
* weight loss \>4.5 kg in month prior to screening
* weight \> 380 lb (due to limit of cellular scale)
* enrollment in other weight loss program
* residing in nursing home or receiving home health care
* unable to attend weight loss group at scheduled times
* impaired hearing
* medication other than metformin, incretin mimetics and incretin enhances for type 2 diabetes
* unstable heart disease in 3 months prior to screening
* furosemide 40 mg or higher (or equivalent)
* chronic kidney disease
* 2 or more errors on cognitive screener
* blood pressure ≥160/100 mmHg
D: Inclusion Criteria:

* age between 18 and 70 years;
* obesity according to the WHO criteria (BMI ≥ 30); ù
* written and informed consent to participate, 4) tech-friendly to receive feedback through smartphone, mail and wearable devices

Exclusion Criteria:

* other severe psychiatric disturbance diagnosed by DSM-V criteria;
* severe visual difficulties,
* important limitations of movement, in particular subjects for which it is not recommended physical activity,
* concurrent medical condition not related to obesity. DSM-V (Thomas et al., 2014) will be used as screening tools for psychiatric disorders.

Answer: B