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

NCT05638516 | Completed

• 1 other identifier: OV-001
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Disorder; Obesity; Overweight

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Vira Self-Care

EXPERIMENTAL

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

Vira + Coaching

EXPERIMENTAL

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

Interventions

Vira mobile app intervention BEHAVIORAL

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.

Vira Self-Care

Vira mobile app intervention + coaching BEHAVIORAL

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.

Vira + Coaching

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ksana Health: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Ksana Health

Eugene, Oregon, 97401, United States

Location

Related Publications (1)

• Weiner LS, Crowley RN, Sheeber LB, Koegler FH, Davis JF, Wells M, Funkhouser CJ, Auerbach RP, Allen NB. Engagement, Acceptability, and Effectiveness of the Self-Care and Coach-Supported Versions of the Vira Digital Behavior Change Platform Among Young Adults at Risk for Depression and Obesity: Pilot Randomized Controlled Trial. JMIR Ment Health. 2024 Sep 19;11:e51366. doi: 10.2196/51366.

  PMID: 39298763 DERIVED

MeSH Terms

Conditions

Mental Disorders; Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Allen, PhD

  Ksana Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 6, 2022
• Study Start: November 7, 2022
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: May 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)