Please select the eligibility criteria that correspond to the clinical trial below.
Title: Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial.
Brief Summary: Overweight and obese men in rural Northeast Nebraska are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care, and a rural milieu that contributes to their sedentary physical activity and unhealthy diet. This study proposes to use a pragmatic randomized controlled trial and community engaged research approaches to 1) determine the feasibility and acceptability of a commercially available, smart phone self-monitoring app (premium-version) plus text-based coaching and daily weighing via Wi-Fi scale intervention for achieving weight loss, 2) determine preliminary efficacy of this intervention group to a comparison group receiving only a self-monitoring app (basic-version) in achieving the outcomes of weight loss (kilogram) and improved dietary and physical activity behaviors (secondary) at 6 months post-baseline, and 3) determine quantitative and qualitative indicators of community capacity to support a contextually relevant weight loss intervention. Eighty men (ages 40-69) with body mass index of 28 or higher, randomly assigned (1:1 ratio) to intervention group or comparison group. Men will complete baseline assessments (weight, % body fat, body mass index height, blood pressure, health history, dietary intake, physical activity frequency/intensity) and receive orientation to the mobile technologies (app features, text messaging, Wi-Fi scale). Men will track their dietary intake, physical activity, and weight on the app for 12 weeks. After the 3-month intervention, post-measure assessments (weight, % body fat, BMI, dietary intake, PA frequency/intensity, technology usability surveys) will be collected at 3 and 6 months post-baseline. At 6 months post-baseline, two groups (n=8 each) of intervention completers will be purposively selected to share their perceptions of the intervention efficacy in an evaluative focus group. A community advisory board comprising local leaders within the men's social network, together with investigators and rural student nurses will guide community outreach efforts for study recruitment, implementation and evaluation. Study findings will be evaluated with the community to inform local dissemination, future intervention revision, and determination of community capacity for support of a larger clinical trial.


Options:
A: Inclusion Criteria:

* Age between 18 and 70
* BMI between 27 and 40 kg/m2
* Access to a computer and WIFI in the home

Exclusion Criteria:

* Weight over 340 lbs
* Physical limitations that prevent walking 1/4 mile without stopping
* Currently participating in another weight loss program or taking weight loss medication
* Currently pregnant, lactating, less than 6-months post-partum, or plans to become pregnant during the 6-month study period
* Uncontrolled hypertension or diabetes
* History of coronary heart disease
* Terminal Illness
* Plans to relocate during the 6-month study period
* Substance Abuse
* Severe psychiatric disorders
* Dementia
B: 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
C: Inclusion Criteria:

* Man age 40-69
* Reside in Northeast Nebraska
* BMI of 28 (kg/m2) or higher (BMI greater than 50 with clinician clearance, maximum weight 396 pounds)
* Smart phone owner with enabled text messaging
* Have an email account
* Answer "no" to all questions on the PAR-Q 17 health history assessment or are willing to get physician evaluation prior to enrolling
* Willing to share self-monitoring logs of eating, activity, and weight with investigative team.

Exclusion Criteria:

* Have recently lost 5% or more of body weight
* Are currently taking medications that cause or are influenced by weight loss
* Have used weight loss app in the past to lose weight
* Family member from same household is enrolled in this study
* Type I diabetes or Type II diabetes with insulin dependence
D: 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.

Answer: C