Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Trial of a Smartphone Application for Weight Loss in Primary Care
Brief Summary: BACKGROUND: The nascent field of mobile health (mHealth) is expanding with impressive speed. In March 2012, experts estimated that 40,000 health related smartphone applications were on the market but little is known about the effectiveness of these programs. To our knowledge, no studies have evaluated whether weight loss can be successfully achieved through use of a smartphone application or how these applications could be used in primary care practice.

PURPOSE: To evaluate the effectiveness of a popular, free smartphone application for weight loss and calorie counting in a primary care setting.

METHODS: The first phase of this study involved a community based participatory approach to select the intervention. Patient focus groups were conducted and analyzed to explore patients' preferences regarding various text-message versus smartphone programs. The second phase of this study, described here, will be a randomized controlled trial with overweight primary care patients exposed to one of two conditions for 6 months: (1) usual care; (2) usual care plus smartphone application, which includes instructing participants on how to use the application and encouraging them to use the applications' reminders and social networking features. The primary outcome of interest is weight change at 3 and 6 months. Two-sample t-test or Wilcoxon rank sum test will be used to compare weight change between groups, as appropriate. ANCOVA models will be used to examine weight change after adjusting for covariates such as education, sex and age. Repeated measures analysis will be carried out to compare weight change between the groups using baseline, 3 month and 6 month data. In addition to an intent-to-treat analysis, the investigators will also conduct a "treatment received" analysis, adjusting for the extent of application use in both the intervention and control arms.

CONCLUSIONS: This study will demonstrate whether a smartphone application introduced in primary care settings and incorporated into the visit can produce weight loss. Study findings could inform a national discourse on the value of smartphone applications in routine clinical practice.


Options:
A: Inclusion Criteria:

* Age: 18 - 65 years
* BMI: 30,0 - 39,9 kg/m2
* Owner of a smartphone
* Caucasian
* No severe diseases
* Informed written consent

Exclusion Criteria:

* Diabetes mellitus
* Severe cardiovascular and/or respiratory disease
* Untreated high blood pressure
* Severe kidney disease
* Active cancer (or in remission)
* Inflammatory bowel disease
* Severe chronic infections and/or inflammations
* Severe mental-health disorders
* Neurodegenerative disorders
* Endocrine diseases
* Lipedema
* Pregnancy and lactation
* Vigorous weight fluctuations (\> 5 kg) in the last 3 months
* Immobility
* Surgery in the last 3 months
* Participation in other intervention studies
* Carrier of pace makers
* Blood donation or transfusion in the last 3 months
B: Inclusion Criteria:

* primary care patient at UCLA Family Health Center or 16th Street Internal Medicine
* age 18 or older,
* English speaking,
* BMI \> 25,
* interested in losing weight,
* smartphone ownership,
* valid email address.

Exclusion Criteria:

* current, planned or previous pregnancy within 6 months,
* currently using a smartphone app for dieting,
* hemodialysis,
* terminal illness
C: Inclusion Criteria:

* age 18 years or older
* BMI between 27-43
* have an Android smartphone,
* has not used app for self-monitoring at least 4 days/week for the past 3 months
* can attend group meetings.

Exclusion Criteria:

* persons who plan to become pregnant
* have diabetes or a medical condition in which weight loss in contraindicated
* unable to walk for exercise
* on a weight loss drug
* had bariatric surgery
* plans to relocate within 3 months of recruitment
* currently in a weight loss program. -
D: Inclusion Criteria:

* 18 through 60 years old
* BMI between 27 - 45 kg/m2
* \< 350 lbs
* Weight stable (no loss or gain \>25 lbs. for the past 6 months)
* Interested in losing weight and not enrolled in a formal weight loss program or taking medications or supplements that may cause weight change
* Own a Smartphone and be willing to install the SMART App
* Reside in the Chicago area for the duration of their participation (12 months)

Exclusion Criteria:

* Unstable medical conditions (uncontrolled hypertension, diabetes - uncontrolled or treated with insulin, uncontrolled hypothyroidism, unstable angina pectoris, transient ischemic attack, cancer undergoing active treatment, cerebrovascular accident or myocardial infarction within the past six months, or Crohn's disease)
* Pregnancy, lactation, or intended pregnancy
* Active suicidal ideation, anorexia, bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence)
* Require assistive device for mobility or current condition that may limit or prevent participation in moderate activity
* Use of pacemaker or other electrical implanted device
* History of bariatric (or LapBand) surgery, or considering or currently on a wait-list for bariatric or LapBand surgery
* May not live with a current or past SMART study participant

Answer: B