Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 1 Study of Fitbit and Apps on Healthy Weight Management in Obese Teens in Primary Care Clinics
Brief Summary: The emerging epidemic of type 2 diabetes mellitus (T2DM) in children is coupled with the increased prevalence of childhood obesity in the last two decades. Obesity during the adolescent years is associated with many adverse health consequences, including T2DM, hyperlipidemia, and psychosocial problems. The first step toward effective obesity management and T2DM prevention is monitoring of physical activity (PA) and dietary intake. With the rapid expansion of cellular networks, and advancements in smartphone technologies, it is now possible to monitor PA and dietary intake and at the same time to transmit data digitally to their primary care providers (PCP). The proposed pilot study will include the collaboration among UCSF, North East Medical Services (NEMS), mHealth teams, and overweight and/or obese adolescents. The study will adapt and implement smartphone-based technologies and integrate these technologies with the Electronic Health Record (EHR) to increase PA and dietary intake. Two specific aims of this proposed study include: (1) adapt fitbit Ultra applications for the smartphone-based technologies and EHR and (2) and assess the feasibility and estimate the effect for patient outcomes (self-efficacy, physical activity, dietary intake, BMI, and lipid profile), at 3 months post intervention between the intervention and control groups. The smartphone app for the intervention group will allow the teens to graphically compare daily PA and dietary intake with the goal, participate in a reward program where they can collect virtual points for achieving the goal, and play interactive games related to PA and diet. A total of 40 overweight and/or obese adolescents at NEMS will be recruited and randomized to the feasibility study (Aim 2).


Options:
A: Inclusion Criteria:

* Having a IMC \>25,
* Being sedentary and
* Have not been submitted to a restrictive diet in the 6 months preceding this study.

Exclusion Criteria:

* Suffered from type 2 diabetes or renal conditions
* Being pregnancy or attempt at pregnancy,
* Being in a maternal lactation period,
* Being underage
* Undergoing antidepressant pharmacological treatment
B: Inclusion Criteria:

* between 13-18 years old
* have a BMI at ≥ 85th percentile, based on CDC growth chart
* own a smartphone;
* have access to a computer with internet access
* be able to read and speak English.

Exclusion Criteria:

* have acute or life-threatening disease
* not be able to engage in activities of daily living
C: Inclusion Criteria:

* Age between 18-70
* Body Mass Index between 30-50
* English Speaking
* Have a smartphone that can be used for study activities

Exclusion Criteria:

* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant within 1 year
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* History of or current traumatic brain injury, dementia or Alzheimer's disease; a history of Multiple Sclerosis, or other neurological disorders
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
* Have no Internet access or unwilling to use personal smartphone for study.
D: Inclusion Criteria (parent):

* Currently age 21-55.
* Body mass index (BMI) of 25-50 kg/m².
* Have one child between the ages of 2-12.
* Own an iPhone running at least iOS11 with a data and text messaging plan.
* Have the ability to read, write, and speak English.

Inclusion Criteria (child):

* Currently age 2-12.

Exclusion Criteria (parent):

* Lost more than 10 pounds in the last 6 months.
* Currently participating in another nutrition or weight loss program.
* Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity.
* Currently pregnant or breastfeeding, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
* Planning to relocate in the next 8 months.
* Will be out of town for 2 weeks or more in the next 8 months.
* Cannot attend two visits at the UNC Weight Research Program clinic.
* Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as determined by items endorsed on the PAR-Q (Physical Activity Readiness Questionnaire).
* Treatment of diabetes with insulin or oral medications that may cause hypoglycemia.
* History of clinically diagnosed eating disorder.
* Diagnosis of schizophrenia or bipolar disorder.
* Hospitalization for a psychiatric diagnosis within the last year.
* Report a past diagnosis of or current symptoms of alcohol or substance dependence.
* Another member of the household (family member or roommate) is a participant or staff member in this study.

Answer: B