NCT05912439

Brief Summary

Despite most adolescents having access to smartphones, few of them seem to use mobile health (mHealth) applications for health improvement, highlighting the apparent lack of interest in mHealth applications among adolescents. Adolescent mHealth interventions have been burdened with high attrition rates, where attrition is often measured at two time points. Research on these interventions among adolescents have frequently lacked detailed time related attrition data alongside analysis of attrition reasons through usage. The objective is to obtain daily attrition rates among adolescents in an mHealth intervention called SidekickHealth and gain a deeper understanding of attrition patterns and reasons along with the function of motivational support, such as altruistic rewards, through analysis of application usage data.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
670

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 22, 2023

Status Verified

May 1, 2023

Enrollment Period

5.7 years

First QC Date

May 30, 2023

Last Update Submit

June 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Application usage

    Time stamp in days, minutes, and seconds off each health activity completed within the mobile application

    From admission to discharge, up to 6 weeks.

Secondary Outcomes (3)

  • Anxiety and depression symptoms

    From admission to discharge, up to 6 weeks.

  • General self-effifcacy

    From admission to discharge, up to 6 weeks.

  • Sleeping habits

    From admission to discharge, up to 6 weeks.

Study Arms (3)

Control

NO INTERVENTION

Measures for participants in control group are obtained at baseline and 42 days later. The control group receives no further contact, access to the mHealth application or information until study-end questionnaire measures are provided.

Treatment-As-Usual

ACTIVE COMPARATOR

For participants in Treatment-As-Usual (TAU) group measures are obtained at baseline and 42 days later. Participants receive an approximately 10 minutes long introduction regarding study specifications and the mHealth application. Active participation in TAU group is defined as downloading the Sidekick app and completing at least 3 health exercises within it. Time of exercise is defined as the timestamp on completion of exercise within any of the three types of exercise categories (physical activity, nutrition and mental health) of the app. Exercise frequency refers to how often a given exercise was completed by a participant in TAU group. Time of attrition is defined as the time stamp of last completing health exercise within the Sidekick throughout intervention period. Participants in TAU group use the application individually throughout trial period without any motivational support.

Behavioral: SidekickHealth

Intervention

EXPERIMENTAL

For participants in intervention group measures are obtained at baseline and 42 days later. Participants receive an approximately 10 minutes long introduction regarding study specifications and the mHealth application. Active participation in intervention group is defined as downloading the Sidekick app and completing at least 3 health exercises within it. Time of exercise is defined as the timestamp on completion of exercise within any of the three types of exercise categories (physical activity, nutrition and mental health) of the app. Exercise frequency refers to how often a given exercise was completed by a participant in TAU group. Time of attrition is defined as the time stamp of last completing health exercise within the Sidekick throughout intervention period. Participants in intervention group receive weekly motivational support in form of individual and group feedback on usage, participation in friendly health task competitions and weekly altruistic rewards for usage.

Behavioral: SidekickHealth

Interventions

SidekickHealthBEHAVIORAL

Usage of mobile application called SidekickHealth.

Also known as: SidekickHealth mHealth application
InterventionTreatment-As-Usual

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children attending the oldest 3 classes in three participating public elementary schools in Iceland are eligible participants. All children in public schools in the municipality are equipped with an iPad from 10 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iceland

Reykjavik, Reykjavik, 101, Iceland

Location

Related Publications (36)

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Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking (blinding) procedures is not done after initial randomisation on group (school) level, since participants are aware of the intervention design, that is whether or not they use a mHealth application
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The study is a randomised controlled study. Group randomisation is used to distinguish three participating schools into control, treatment-as-usual (TAU) and intervention groups. Measures are obtained at baseline and 42 days later. Participants in both the TAU group and the intervention group receive an approximately 10 minutes long introduction regarding the study specifications and the application. The control group receive no further contact, access to the application or information until study-end questionnaire measures. Participants in the intervention group are randomly assigned to teams consisting of 8 individuals that collectively and individually compete in point collection through completion of in-app health tasks. Participation in the TAU group and intervention group is defined as downloading the Sidekick app and completing at least 3 health exercises within it.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 22, 2023

Study Start

August 15, 2017

Primary Completion

May 1, 2023

Study Completion

December 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

The plan is not to share individual participant data since this is a study with Icelandic adolescent participants and the Icelandic Data Protection and the Processing of Personal Data (DPPPD) laws are very strict on the matter.

Locations