Please select the arm or intervention descriptions that belong 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: Arm Label: Low carb - App-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Arm Label: Low carb - Newsletter-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Arm Label: Low fat - App-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Arm Label: Low fat - Newsletter-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Intervention Type: BEHAVIORAL; Name: Weight maintenance intervention; Assigned to Arm(s): Low carb - App-based group, Low carb - Newsletter-based group, Low fat - App-based group, Low fat - Newsletter-based group
B: Arm Label: Smartphone Application; Type: EXPERIMENTAL; Interventions: Other: Smartphone Application | Arm Label: Usual primary care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Smartphone Application; Assigned to Arm(s): Smartphone Application
C: Arm Label: Experimental: Group Sessions; Type: EXPERIMENTAL; Interventions: Behavioral: Group Sessions, Behavioral: Feedback, Behavioral: Self-monitoring | Arm Label: Active Comparator: Self-Monitoring; Type: EXPERIMENTAL; Interventions: Behavioral: Self-monitoring | Arm Label: Experimental: Feedback; Type: EXPERIMENTAL; Interventions: Behavioral: Feedback, Behavioral: Self-monitoring | Intervention Type: BEHAVIORAL; Name: Group Sessions; Assigned to Arm(s): Experimental: Group Sessions | Intervention Type: BEHAVIORAL; Name: Feedback; Assigned to Arm(s): Experimental: Feedback, Experimental: Group Sessions | Intervention Type: BEHAVIORAL; Name: Self-monitoring; Assigned to Arm(s): Active Comparator: Self-Monitoring, Experimental: Feedback, Experimental: Group Sessions
D: Arm Label: Step 1: Optimal First Line Treatment; Type: EXPERIMENTAL; Interventions: Behavioral: Step 1 Treatment: APP, Behavioral: Step 1 Treatment: APP + Coaching | Arm Label: Step 2: Optimal Strategy to Address Nonresponse; Type: EXPERIMENTAL; Interventions: Behavioral: Step 2 Treatment Strategy: Modest Step-up, Behavioral: Step 2 Treatment Strategy: Vigorous Step-up | Intervention Type: BEHAVIORAL; Name: Step 1 Treatment: APP; Assigned to Arm(s): Step 1: Optimal First Line Treatment | Intervention Type: BEHAVIORAL; Name: Step 1 Treatment: APP + Coaching; Assigned to Arm(s): Step 1: Optimal First Line Treatment | Intervention Type: BEHAVIORAL; Name: Step 2 Treatment Strategy: Modest Step-up; Assigned to Arm(s): Step 2: Optimal Strategy to Address Nonresponse | Intervention Type: BEHAVIORAL; Name: Step 2 Treatment Strategy: Vigorous Step-up; Assigned to Arm(s): Step 2: Optimal Strategy to Address Nonresponse

Answer: B