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

Not Applicable

Completed

• Conditions: Obesity; Mental Health Disorder; Overweight

• Registration Number: NCT05638516
• Lead Sponsor: Ksana Health

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).

Study Timeline

• Study Start: 2022-11-07
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-06
• Status Verified: 2023-05
• Primary Completion: 2023-05-06
• Study Completion: 2023-05-06
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in depressive symptoms	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.
Number of active days in the Vira mobile app intervention and health coaching platform	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.
Number of features used	12 weeks	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	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.

Trial Locations

Locations (1)

Ksana Health; 🇺🇸 Eugene, Oregon, United States