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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05638516
Other study ID # OV-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 7, 2022
Est. completion date May 6, 2023

Study information

Verified date May 2023
Source Ksana Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date May 6, 2023
Est. primary completion date May 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Ksana Health Eugene Oregon

Sponsors (2)

Lead Sponsor Collaborator
Ksana Health Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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