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OpenTrials
Completed

NCT Number: NCT05638516

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.

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Key information

Conditions

Mental Health Disorder Body Weight Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ksana Health

Eugene, Oregon, 97401, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Change in depressive symptoms

    Time frame: 12 weeks

    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.

  2. Number of active days in the Vira mobile app intervention and health coaching platform

    Time frame: 12 weeks

    To measure feasibility of implementation, the total number of active days using Vira during the study will be objectively collected via the Vira platform.

  3. Number of features used

    Time frame: 12 weeks

    To measure feasibility of implementation, the total number of features used during the study will be objectively collected via the Vira platform.

  4. Acceptability of the mobile app intervention

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ksana Health

Industry

Collaborators

  • Novo Nordisk A/S

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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