NCT05638516

Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Ksana Health · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to test the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in youth (aged 18-25 years) with elevated depressive symptoms who are overweight/obese and/or self-report parental history of overweight/obesity. Eligible participants will be randomly assigned to one of two groups: one group will use the Vira mobile app intervention with support from a health coach, and the other group will use the Vira mobile app intervention without coaching. Both groups will use the app for 12 weeks.

Detailed description

The primary aim of this project is to examine the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in a 2 x 2 (gender x condition) designed pilot study in a sample of 100 youth (18-25 years old) with (1) elevated depressive symptoms (PHQ-8 score ≥10) and (2) overweight/obesity (BMI ≥ 25 and/or reporting a parental history of overweight/obesity). The study will examine the feasibility and utilization of the mobile app intervention with coaching compared to that of the mobile app intervention without coaching. This is an exploratory pilot study; therefore, no formal sample size calculation was conducted. It is anticipated that 1,000 individuals will be screened, of which 20% will be eligible, and that 50% of those eligible will agree to participate (final N = 100, 50 per arm).

Conditions

• Mental Health Disorder
• Obesity
• Overweight

Interventions

Type	Name	Description
BEHAVIORAL	Vira mobile app intervention	The Vira app is installed on the participant's phone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also so prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Users will be asked to use Vira for 12 weeks.
BEHAVIORAL	Vira mobile app intervention + coaching	The Vira app can also be supported by a health coach. The health coach interacts with the user (via an instant messaging platform) and who also schedules just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan. The Vira Health Coach Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the coach's workflow.

Timeline

• Start date: 2022-11-07
• Primary completion: 2023-05-06
• Completion: 2023-05-06
• First posted: 2022-12-06
• Last updated: 2023-05-18

Locations

1 site across 1 country: United States