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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Mental Health Disorder
• Intervention / Treatment: Behavioral: Vira mobile app intervention; Behavioral: Vira mobile app intervention + coaching

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).

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Ksana Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-25
• Live in the United States
• English fluency and literacy
• Have access to an Android or iOS device
• Elevated depressive symptoms (PHQ-8 score of 10 or above)
• Overweight (BMI of 25 or above) OR reporting a parental history of overweight or obesity

Exclusion Criteria:

• Previous participation in this study
• Major mental or physical illness that will interfere with completing intervention and/or assessment activities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vira Self-Care; 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. The Vira app can be used as a standalone product. After an initial 10-day period, during which the app assesses the relationship between the user's patterns of behavior and their day-to-day variations in mental health and wellbeing using passive mobile sensing, the user is able to access a personalized behavior change goal that is support by in app information and functionality.	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.
Experimental: Vira + 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms	Pre- to post-intervention changes in depressive symptoms will be assessed by the Patient Health Questionnaire (PHQ-8) an 8-item participant-report measure for screening for depression and for establishing depression severity. The total score ranges from 0-24, with a higher score indicating greater depression symptom severity.	12 weeks
Number of active days in the Vira mobile app intervention and health coaching platform	To measure feasibility of implementation, the total number of active days using Vira during the study will be objectively collected via the Vira platform.	12 weeks
Number of features used	To measure feasibility of implementation, the total number of features used during the study will be objectively collected via the Vira platform.	12 weeks
Acceptability of the mobile app intervention	Acceptability of the mobile app intervention and health coaching platform will be assessed using 11 items adapted from the Technology Acceptance Model. Scores range from 11 to 77, with higher scores indicating greater acceptability.	12 weeks

Collaborators and Investigators

• Sponsor: Ksana Health
• Collaborators: Novo Nordisk A/S
• Investigators: Principal Investigator: Nick Allen, PhD, Ksana Health

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Mental Disorders; Overweight
• Other Study ID Numbers: OV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No