Please select the eligibility criteria that correspond to the clinical trial below.
Title: Facilitating Weight Loss and Reversing Type 2 Diabetes (T2D) by Means of a Collaborative eHealth Lifestyle Coaching Intervention in Primary Care - A 2-year Randomised Controlled Trial
Brief Summary: Background: Systematic reviews conclude that Internet and mobile interventions can significantly change lifestyle in a short time span. The applicant has developed a collaborative eHealth tool (LIVA) that has led to a significant and clinically relevant weight loss of 5.4 to 7.0 kg over 12 to 20 months in primary care settings. The objective of this study is to develop and evaluate a model targeting long-term effects using eHealth coaching assisted by machine learning-generated advice intervention for overweight patients at risk of developing diabetes as well as current type 2 diabetes (T2D) patients in a primary care setting.

Methods and analysis: Randomized controlled trial with 1-year intervention and 1-year maintenance. The primary outcome is weight loss and the secondary outcome is reduced HbA1c level. The study will comprise 340 overweight patients of which 170 will have T2D. Individual data will be obtained from clinical measurements, questionnaire data, registered from the collaborative eHealth tool, as well as other registry data at baseline and at 6, 12 and 24 months. The core of the intervention is the establishment of an empathic relationship and ongoing real-life coaching using the LIVA app (working together with native iOS and Android) and Internet for patients combined with an effective coaching module supported by machine learning methods. The intervention will be compared with usual care.


Options:
A: 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
B: Inclusion Criteria:

* BMI 30-45
* Weight stable
* Own a Smartphone and be willing to install our Smartphone app
* Willing to conduct video conference calls with study staff

Exclusion Criteria:

* Enrolled in any formal weight loss program
* Taking anti-obesity medications
* Not taking medications that may cause weight gain
* Unstable medical conditions
* Diabetes requiring insulin supplementation
* Crohn's Disease
* Diagnosis of obstructive sleep apnea requiring intervention (i.e., CPAP)
* Assistive devices for mobility
* Hospitalizations for a psychiatric disorder within the past 5 years
* Cardiovascular disease symptoms while performing moderate intensity exercise
* Pregnancy, trying to get pregnant, or lactating.
* Bulimia or binge eating disorder
* Reports of active suicidal ideation
* Current substance abuse or dependence besides nicotine dependence
C: Inclusion criteria:

* BMI ≥ 30 kg/m2 and \< 45 kg/m2
* Aged 18 -70 years

Exclusion criteria:

* Fails to provide informed consent
* Fails to complete the initial questionnaire
* No Internet access in own home through computer or smartphone
* Is pregnant or actively trying to get pregnant
* Experiences serious or life-threatening disease
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: C