Please select the arm or intervention descriptions that belong 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: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Smartphone + Text Messaging with Health Coach | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Smartphone + Text Messaging with Health Coach; Assigned to Arm(s): Intervention
B: Arm Label: Smartphone App Participants (APP); Type: EXPERIMENTAL; Interventions: Behavioral: Smartphone App Participants (APP) | Arm Label: Diabetes Prevention Program Participants (DPP); Type: EXPERIMENTAL; Interventions: Behavioral: Diabetes Prevention Program Participants (DPP) | Intervention Type: BEHAVIORAL; Name: Smartphone App Participants (APP); Assigned to Arm(s): Smartphone App Participants (APP) | Intervention Type: BEHAVIORAL; Name: Diabetes Prevention Program Participants (DPP); Assigned to Arm(s): Diabetes Prevention Program Participants (DPP)
C: Arm Label: Online dietician lifestyle counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Online dietetic lifestyle counseling | Arm Label: Usual care; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Usual care | Intervention Type: BEHAVIORAL; Name: Online dietetic lifestyle counseling; Assigned to Arm(s): Online dietician lifestyle counseling | Intervention Type: BEHAVIORAL; Name: Usual care; Assigned to Arm(s): Usual care
D: Arm Label: Podcasting + mobile media; Type: EXPERIMENTAL; Interventions: Behavioral: Podcasting + mobile media | Arm Label: Podcasting; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Podcasting + mobile media | Intervention Type: BEHAVIORAL; Name: Podcasting + mobile media; Assigned to Arm(s): Podcasting, Podcasting + mobile media

Answer: C