Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effectiveness of a Mobile Application as an Adjunct to Medical Advice to Promote Healthy Habits (Diet and Sport) in a Population of Patients Obese or Overweight Adults Patients
Brief Summary: INTRODUCTION: Obesity is the most common metabolic problem and its genesis and maintenance there is always a positive energy balance, with less energy expenditure than that obtained from the intake. Low physical activity is often an important factor in this lower spending. Medical advice is useful for determining changes in the habits of life of patients, however, the changes produced by the council do not last over time, so it would be necessary to establish enforcement mechanisms as with mobile technology, because it could improve the adhesion of obese patients to therapy. OBJECTIVE: Primary: To evaluate the effectiveness of an app as an adjunct to medical advice to promote healthy living habits (sport and diet) to lose weight in a population of obese or overweight adult patients. MATERIAL AND METHODS: Open randomized controlled clinical trial with clinical practice (health advice for physical activity and sport). STUDY POPULATION: Obese or overweight adults patients of Araba aged between 18-45 years who be in Contemplation stage with smartphone. Variables: Primary endpoint: Weight (kg); Secondary variables: BMI (kg/cm2); blood pressure (mm Hg); heart rate; Plasma cholesterol (mg / dl); HbA1c; score on the satisfaction questionnaire; index of physical exercise (IPAQ) (METs); quitting tobacco (yes / no); Waist circumference (cm). Statistical analysis: The primary endpoint (weight reduction) will be evaluated by covariance analysis adjusting by baseline weight, and other confounding variables (sex, age, level of education..) Simple size: 48 patients by arm plus 20% to cover losses to follow.


Options:
A: Inclusion Criteria:

* age: 50-75y old
* BMI ≥25 and ≤45 kg/m2
* a diagnosis of prediabetes AND/OR fasting glucose 100 mg/dL and/or HbA1c 5.7% OR Type 2 Diabetes diet-controlled and/or treated with metformin AND meeting 2 or more of the following metabolic syndrome criteria:

  * diagnosis of hypertension on stable medication regimen
  * blood pressure \>120/\>80 mmHg
  * A diagnosis of dyslipidemia on stable regimen
  * triglycerides 150 mg/dL
  * HDL cholesterol men \<40 mg/dL and women \<50 mg/dL
  * waist circumference men: \>102 cm (\>40 in); women \>88 cm (\>35 in)
* in possession of a smart phone (iPhone or Android)
* 70% of days with logging adherence (2 or more log entries/day separated by at least 5h)
* Sleep duration 6-h, with habitual self-reported wake up time \>5AM and before 11 AM and average self reported bed time \<2AM
* habitually eat breakfast
* with weight stability within 5% of screening for the last 3 months
* English speaking (the App has not yet been translated)
* must live in the New York City metro area

Exclusion criteria:

* sleep disorder, e.g. known obstructive sleep apnea (OSA) on CPAP, severe OSA with apnea-hypopnea index \>30 events/h, significant daytime symptoms of OSA, periodic limb movements of sleep, narcolepsy, current shift work or in last 6-mo, travel more than 1 time zone during intervention; severe insomnia with score 15 on Insomnia Severity Index
* significant organ system dysfunction/disease: severe pulmonary, kidney or cardiovascular disease; evidence of active illness (e.g., fever)
* history of seizure disorder
* previous bariatric surgery or on weight loss medication
* history of or current significant food intake or psychiatric disorder
* use of dietary supplements and/or medications known to affect sleep, circadian rhythms or metabolic function
* smoking tobacco or using illegal or recreational drugs
* consume excessive alcohol (women: \>14 drinks/wk; men: \>21 drinks/wk)
* anemia (hemoglobin \<10 g/dl and hematocrit \<30%)
* have conditions that render individual unable to complete all testing procedures \[e.g., unable to stay overnight or frequent travel across 1 time zones\]
* extreme early and late chronotypes (\> 2AM bed time and wake up time before 5AM and \> 11AM)
* severe food allergies
* unwilling/unable to provide informed consent
B: 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
C: Inclusion Criteria:

* BMI\> = 25 mg / kg
* Holder smartphone
* Sign informed consent

Exclusion Criteria:

* Presence of physical or mental illnesses that prevent the realization of physical activity
* Be participating in another research project
* Pregnancy or lactation
* Patients who are on diet or drug treatment for weight loss
* History of myocardial infarction or stroke
D: Inclusion

* age 17-25 years
* Current CSCC student
* Identify as Black
* BMI ≥ 25
* Speaks and reads English
* Interested in losing weight through diet and physical activity changes
* Owns a smartphone or iPhone Operating System (iOS) or Android compatible device
* Ability to return for 12-month visit

Exclusion

* currently pregnant or planning to become pregnant in next 12 months
* Currently participating in another structured weight loss program or taking weight loss medications or medication known to increase weight
* Lost 10% or more of body weight in past 6 months
* Screens positive for disordered eating symptoms
* diagnosed with type I diabetes

Answer: C