Please select the arm or intervention descriptions that belong 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: Arm Label: SC; Type: EXPERIMENTAL; Interventions: Behavioral: Self-monitoring skills | Arm Label: TECH; Type: EXPERIMENTAL; Interventions: Behavioral: Self-monitoring skills, Behavioral: Technology | Arm Label: TECH+INT; Type: EXPERIMENTAL; Interventions: Behavioral: Self-monitoring skills, Behavioral: Technology, Behavioral: Interventionist Contact | Intervention Type: BEHAVIORAL; Name: Self-monitoring skills; Assigned to Arm(s): SC, TECH, TECH+INT | Intervention Type: BEHAVIORAL; Name: Technology; Assigned to Arm(s): TECH, TECH+INT | Intervention Type: BEHAVIORAL; Name: Interventionist Contact; Assigned to Arm(s): TECH+INT
B: Arm Label: intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: APP + health advice | Arm Label: control group; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: health advice | Intervention Type: BEHAVIORAL; Name: APP + health advice; Assigned to Arm(s): intervention group | Intervention Type: BEHAVIORAL; Name: health advice; Assigned to Arm(s): control group
C: Arm Label: Mobile Technology Plus (MT+); Type: EXPERIMENTAL; Interventions: Behavioral: Mobile Technology Plus | Arm Label: Mobile Technology (MT); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Mobile Technology | Intervention Type: BEHAVIORAL; Name: Mobile Technology Plus; Assigned to Arm(s): Mobile Technology Plus (MT+) | Intervention Type: BEHAVIORAL; Name: Mobile Technology; Assigned to Arm(s): Mobile Technology (MT)
D: Arm Label: Behavioral Weight Loss Maintenance + Healthy Thinking; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight Loss Maintenance + Healthy Thinking | Arm Label: Behavioral Weight Loss Maintenance Treatment + Future Thinking; Type: EXPERIMENTAL; Interventions: Behavioral: Weight Loss Maintenance Treatment + Future Thinking | Intervention Type: BEHAVIORAL; Name: Weight Loss Maintenance + Healthy Thinking; Assigned to Arm(s): Behavioral Weight Loss Maintenance + Healthy Thinking | Intervention Type: BEHAVIORAL; Name: Weight Loss Maintenance Treatment + Future Thinking; Assigned to Arm(s): Behavioral Weight Loss Maintenance Treatment + Future Thinking

Answer: C