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

Primary Purpose

Mental Health Disorder, Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vira mobile app intervention
Vira mobile app intervention + coaching
Sponsored by
Ksana Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health Disorder

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ksana Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Vira Self-Care

Vira + Coaching

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 23, 2022
Last Updated
May 17, 2023
Sponsor
Ksana Health
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05638516
Brief Title
Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product
Official Title
Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
May 6, 2023 (Actual)
Study Completion Date
May 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ksana Health
Collaborators
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Disorder, Obesity, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vira Self-Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Vira + Coaching
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vira mobile app intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Vira mobile app intervention + coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depressive symptoms
Description
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.
Time Frame
12 weeks
Title
Number of active days in the Vira mobile app intervention and health coaching platform
Description
To measure feasibility of implementation, the total number of active days using Vira during the study will be objectively collected via the Vira platform.
Time Frame
12 weeks
Title
Number of features used
Description
To measure feasibility of implementation, the total number of features used during the study will be objectively collected via the Vira platform.
Time Frame
12 weeks
Title
Acceptability of the mobile app intervention
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Allen, PhD
Organizational Affiliation
Ksana Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ksana Health
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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